510(k) Report

510(k) · Cleared

Cleared

ExcelsiusGPS Spine 1.1 Interbody Module

K191100510(k) TraditionalCleared Jul 24, 201990-day reviewClass II21 CFR 882.4560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Globus Medical, Inc. · OLO Orthopedic Stereotaxic Instrument

Cleared on Jul 24, 2019 as substantially equivalent to K171651 (Globus Medical, Inc., 2017) and 7 other predicates after a 90-day review. Its family tree reaches back 19 generations to 2004. 4 of the 728 devices in its family, counting itself, have a Class I recall. 42 later devices descend from it.

Decided
Jul 24, 2019
Review
90 days
Class
Class II
Product code
OLO
Recalls
None
Predicates
8

Its longest line of descent runs back 19 generations to K040583 (2004). 685 ancestors in all, the oldest K781443 (1978). 42 later devices descend from it, 11 citing it directly. 4 of the 728 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2017: 3 other ancestors2016: 3 other ancestors, 1 with a Class I recall12014: 13 other ancestors2013: 21 other ancestors2012: 15 other ancestors2011: 33 other ancestors2015: 14 other ancestors, 1 with a Class I recall12009: 35 other ancestors2008: 62 other ancestors2005: 49 other ancestors2004: 63 other ancestors2003: 39 other ancestors2001: 40 other ancestors2010: 32 other ancestors, 1 with a Class I recall12007: 30 other ancestors2006: 34 other ancestors2002: 32 other ancestors1999: 21 other ancestors1998: 18 other ancestors1996: 17 other ancestors2000: 26 other ancestors1993: 4 other ancestors1990: 2 other ancestors1997: 12 other ancestors1995: 15 other ancestors1979: 2 other ancestors1978: 1 other ancestor1994: 7 other ancestors1989: 5 other ancestors1987: 3 other ancestors1985: 2 other ancestors1984: 2 other ancestors1981: 2 other ancestors1992: 3 other ancestors1988: 2 other ancestors1991: 1 other ancestor1986: 2 other ancestors1980: 1 other ancestor2021: 2 descendants cleared, 1 with a Class I recall12025: 11 descendants cleared2020: 1 descendant cleared2024: 12 descendants cleared2022: 1 descendant cleared2026: 13 descendants cleared2023: 2 descendants cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) ×2: 2 generations cleared close together, K121680 (2012), K122862 (2012) K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143375 · CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments · Medtronic Sofamor Danek USA, Inc. · 2015K153203 · Navigation Instruments · Globus Medical, Inc. · 2016K161591 · QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments · Globus Medical, Inc. · 2016K171651 · Excelsius GPS · Globus Medical, Inc. · 2017 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 29 other ancestors, 1 with a Class I recall13 generations back: 71 other ancestors, 1 with a Class I recall14 generations back: 132 other ancestors, 1 with a Class I recall15 generations back: 158 other ancestors6 generations back: 127 other ancestors7 generations back: 76 other ancestors8 generations back: 35 other ancestors9 generations back: 18 other ancestors10 generations back: 9 other ancestors11 generations back: 2 other ancestors12 generations back: 2 other ancestors 1 generation forward: 11 descendants, 1 with a Class I recall12 generations forward: 14 descendants3 generations forward: 11 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K171651 · Excelsius GPS · Globus Medical, Inc. · 2017 · recalledK161591 · QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments · Globus Medical, Inc. · 2016K153203 · Navigation Instruments · Globus Medical, Inc. · 2016K143375 · CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments · Medtronic Sofamor Danek USA, Inc. · 2015K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K122862 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50+5
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 15 generations between
  3. 3 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
  4. 2 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
  5. 1 generation backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
  6. This deviceK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
  7. Descendant · cites it directly · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
  8. Descendant · cites it directly · 9 of its ownK211616 ExcelsiusHubGlobus Medical, Inc. · 2021 · Recalled (Class I)
  9. Descendant · 2 generations on · 6 of its ownK241846 E3D™-C Interbody SystemEvolution Spine · 2024
  10. Descendant · 2 generations on · 5 of its ownK243635 aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024
  11. Descendant · 2 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
Show all 19 generations
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 7 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 6 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 5 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 4 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
  17. 3 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
  18. 2 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
  19. 1 generation backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
  20. This deviceK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2020: 12021: 22022: 12023: 22024: 122025: 112026: 13
2020high 13 (2026) · low 1 (2020)2026

Class I recalls in this family

  • K153660 StealthStation System with Cranial Software2 generations back · 2016
  • K150216 Synergy Cranial3 generations back · 2015
  • K100952 Modification to Synthes Matrix System4 generations back · 2010
  • K211616 ExcelsiusHubcites it directly · 2021

Most influential descendants

Showing 5 of 42 · See all
  • K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · cites it directly23descendants
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · cites it directly9descendants
  • K241846E3D™-C Interbody SystemEvolution Spine · 2024 · 2 generations on6descendants
  • K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024 · 2 generations on5descendants
  • K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−16K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−14K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−12K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−11K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−10K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−9K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−8K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−7K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−6K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−5K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−4K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015—
−3K153203Navigation InstrumentsGlobus Medical, Inc.2016—
−2K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.2016—
−1K171651Excelsius GPSGlobus Medical, Inc.20171
0 (this device)K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.2019—
+1K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer…Globus Medical, Inc.2022—
+1K211616ExcelsiusHubGlobus Medical, Inc.2021Class I
+2K241846E3D™-C Interbody SystemEvolution Spine2024—
+2K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.2024—
+2K231199Solar Lumbar Interbody Fusion SystemDegen Medical2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
197920
198010
198120
198420
198520
198620
198730
198820
198950
199020
199110
199230
199340
199470
1995150
1996170
1997120
1998180
1999210
2000260
2001400
2002320
2003390
2004630
2005490
2006340
2007300
2008620
2009350
2010321
2011330
2012150
2013210
2014130
2015141
201631
201730

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202121
202210
202320
2024120
2025110
2026130
FIG. 1 — Lineage of K191100, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OLO device

  1. #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K171651Excelsius GPS
Summary page 4
…§882.4560 Stereotaxic instrument Product Code(s): OLO Regulatory Class: II Primary Predicate: ExcelsiusGPS® (K171651) Other Predicates: Medtronic StealthStation S8 (K170011) Medtronic Navigated Elevate Inserter & Disc Prep (K16…
Globus Medical, Inc.20171
*K170011StealthStation S8 Spine Software v1.0.0
Summary page 4
…Product Code(s): OLO Regulatory Class: II Primary Predicate: ExcelsiusGPS® (K171651) Other Predicates: Medtronic StealthStation S8 (K170011) Medtronic Navigated Elevate Inserter & Disc Prep (K163581) SUSTAIN® Lumbar (K130478)…
Medtronic Navigation2017—
*K163581Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
Summary page 4
…Primary Predicate: ExcelsiusGPS® (K171651) Other Predicates: Medtronic StealthStation S8 (K170011) Medtronic Navigated Elevate Inserter & Disc Prep (K163581) SUSTAIN® Lumbar (K130478) CALIBER® (K102293) RISE® (K113447)…
Medtronic Sofamor Danek USA, Inc.2017—
*K130478Sustain and Sustain Radiolucent Spacers
Summary page 4
…Other Predicates: Medtronic StealthStation S8 (K170011) Medtronic Navigated Elevate Inserter & Disc Prep (K163581) SUSTAIN® Lumbar (K130478) CALIBER® (K102293) RISE® (K113447) ALTERA® (K140411)…
Globus Medical, Inc.2013—
*K102293Caliber Spacer
Summary page 4
…tion S8 (K170011) Medtronic Navigated Elevate Inserter & Disc Prep (K163581) SUSTAIN® Lumbar (K130478) CALIBER® (K102293) RISE® (K113447) ALTERA® (K140411) ELSA® (K161379) Purpose: The purpose…
Globus Medical, Inc.2011—
*K113447Rise Spacer
Summary page 4
…Medtronic Navigated Elevate Inserter & Disc Prep (K163581) SUSTAIN® Lumbar (K130478) CALIBER® (K102293) RISE® (K113447) ALTERA® (K140411) ELSA® (K161379) Purpose: The purpose of this submission is to request c…
Globus Medical, Inc.2012—
*K140411Altera Spacer
Summary page 4
…r & Disc Prep (K163581) SUSTAIN® Lumbar (K130478) CALIBER® (K102293) RISE® (K113447) ALTERA® (K140411) ELSA® (K161379) Purpose: The purpose of this submission is to request clearance of the ExcelsiusGPS® Spine 1…
Globus Medical, Inc.201422
*K161379ELSA Spacers
Summary page 4
…SUSTAIN® Lumbar (K130478) CALIBER® (K102293) RISE® (K113447) ALTERA® (K140411) ELSA® (K161379) Purpose: The purpose of this submission is to request clearance of the ExcelsiusGPS® Spine 1.1 Interbody Module software and na…
Globus Medical, Inc.2016—

Also cleared against K171651: 27 other devices →

What descends from it? (42)

See all 42

11 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223
K211616ExcelsiusHub Class IGlobus Medical, Inc.20219
K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.20205
K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics20242
K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241
K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260
K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250
K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250
K241525ExcelsiusXR™Globus Medical, Inc.20250
K243814NuVasive Pulse SystemGlobus Medical, Inc.20250

Has anything in its family been recalled? (4 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 2 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
  • K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 3 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · Cites it directly · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 7 months on median.
  • 86 of the 685 ancestors have a recall of any class; 3 have a Class I recall.
  • Of its descendants, K222270 (Globus Medical, Inc., 2022) has gone furthest, with 23 descendants of its own.
  • 27 other devices also cite its predicate K171651.

How does its category compare?

All OLO devices

OLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · OLO

40in 2025

2009: 112010: 92011: 112012: 72013: 72014: 102015: 102016: 142017: 332018: 242019: 352020: 342021: 282022: 402023: 452024: 442025: 402026 (partial year): 42
2007high 45 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLO

119in 2025

2009: 126 days median2010: 113 days median2011: 138 days median2012: 129 days median2013: 137 days median2014: 119 days median2015: 176 days median2016: 120 days median2017: 91 days median2018: 97 days median2019: 95 days median2020: 89 days median2021: 91 days median2022: 89 days median2023: 90 days median2024: 90 days median2025: 119 days median2026 (partial year): 109 days median
2007high 176 (2015) · low 89 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OLO

1in 2025

2010: 12011: 12012: 12014: 32015: 22016: 32017: 22018: 12019: 12020: 62022: 52023: 7, 1 Class I2024: 42025: 12026 (partial year): 6
2007high 7 (2023) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OLO

3,306in 2025

2008: 12009: 42010: 42011: 102012: 602013: 362014: 2452015: 4662016: 7502017: 1,0762018: 1,2302019: 1,5852020: 2,7462021: 1,6962022: 1,5682023: 1,4932024: 2,3532025: 3,306
2007high 3,306 (2025) · low 0 (2007)2025

MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20091112604
2010911314
201111138110
20127129160
20137137036
2014101193245
2015101762466
2016141203750
2017339121,076
2018249711,230
2019359511,585
2020348962,746
2021289101,696
2022408951,568
202345907 (1)1,493
2024449042,353
20254011913,306
2026421096—

What is it indicated for?

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial

positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding

compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid

patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and

orthopedic bone screws and interbody fusion devices.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K171651

27 other devices cite the same predicate.

  • K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc. · 2026
  • K254148VERTICALE GPS InstrumentsSilony Medical GmbH · 2026
  • K251780iGPS Navigation InstrumentsSI-BONE, Inc. · 2025
  • K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation…Innovasis, Inc. · 20251 recall
  • K241525ExcelsiusXR™Globus Medical, Inc. · 2025
  • K243326Dynamis Robotic Surgical SystemLEM Surgical AG · 2025

More from Globus Medical, Inc.

184 FDA decisions under this applicant name. See the company

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc. · 2026
  • K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System…Globus Medical, Inc. · 2026
  • K253401SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026

Recent decisions in OLO

The OLO category page

  • K2604037D Surgical System (10-0001)7D Surgical ULC · 2026
  • K263234TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2026
  • K263154CarboClear® Cervical Navigated InstrumentsCarboFix Orhtopedics, Ltd. · 2026
  • K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE · 2026
  • K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp. · 2026

https://510kreport.com/device/K191100 · printed Nov 4, 2026

Cite this page

510(k) Report. “K191100: ExcelsiusGPS Spine 1.1 Interbody Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K191100

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026