510(k) Report

510(k) · Cleared

Cleared

ELSA Spacers

K161379510(k) TraditionalCleared Sep 29, 2016134-day reviewClass II21 CFR 888.3080

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

Globus Medical, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on Sep 29, 2016 as substantially equivalent to K102293 (Globus Medical, Inc., 2011) and 6 other predicates after a 134-day review. Its family tree reaches back 17 generations to 1984. 1 of the 435 devices in its family, counting itself, has a Class I recall. 155 later devices descend from it.

Decided
Sep 29, 2016
Review
134 days
Class
Class II
Product code
OVD
Recalls
None
Predicates
7

Its longest line of descent runs back 17 generations to K841189 (1984). 279 ancestors in all, the oldest K792352 (1979). 155 later devices descend from it, 13 citing it directly. 1 of the 435 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2015: 4 other ancestors2014: 6 other ancestors2013: 13 other ancestors2011: 16 other ancestors2012: 8 other ancestors2010: 15 other ancestors2009: 18 other ancestors2008: 35 other ancestors2007: 16 other ancestors1999: 4 other ancestors2006: 13 other ancestors2005: 22 other ancestors2004: 37 other ancestors2003: 19 other ancestors2002: 13 other ancestors1996: 3 other ancestors2001: 11 other ancestors2000: 4 other ancestors1993: 1 other ancestor1998: 2 other ancestors1980: 1 other ancestor1979: 1 other ancestor2019: 6 descendants cleared2021: 12 descendants cleared, 1 with a Class I recall12025: 29 descendants cleared2023: 23 descendants cleared2016: 1 descendant cleared2018: 3 descendants cleared2022: 16 descendants cleared2024: 31 descendants cleared2020: 9 descendants cleared2017: 2 descendants cleared2026: 23 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007×4: 4 generations cleared close together, K072120 (2007), K080083 (2008), K073109 (2008), K081849 (2008) K091301 · Life Spine Stand-Alone Spacer System · Life Spine · 2009K100802 · Aesculap Implant Systems Sibd Spinal System · Aesculap Implant Systems, Inc. · 2010K111122 · Aesculap Sibd XP Spinal System · Aesculap Implant Systems, Inc. · 2011K141942 · Midline II TI · Centinel Spine, Inc. · 2014K150643 · Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti · Centinel Spine, Inc. · 201519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 25 other ancestors3 generations back: 53 other ancestors4 generations back: 69 other ancestors5 generations back: 54 other ancestors6 generations back: 31 other ancestors7 generations back: 16 other ancestors8 generations back: 6 other ancestors9 generations back: 2 other ancestors 1 generation forward: 13 descendants2 generations forward: 34 descendants, 1 with a Class I recall13 generations forward: 36 descendants4 generations forward: 44 descendants5 generations forward: 21 descendants6 generations forward: 5 descendants7 generations forward: 2 descendants K150643 · Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti · Centinel Spine, Inc. · 2015K141942 · Midline II TI · Centinel Spine, Inc. · 2014K111122 · Aesculap Sibd XP Spinal System · Aesculap Implant Systems, Inc. · 2011K100802 · Aesculap Implant Systems Sibd Spinal System · Aesculap Implant Systems, Inc. · 2010K091301 · Life Spine Stand-Alone Spacer System · Life Spine · 2009K081849 · Blackstone Pillar SA Partial Vertebral Body Replacement Device · Blackstone Medical, Inc. · 2008 · recalledK073109 · Stalif TT Intervertebral Body Fusion System · Surgicraft, Ltd. · 2008K080083 · Intrepid Spinal System · Medtronic Sofamor Danek · 2008 · recalledK072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−15−10−50+5
  1. Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 13 generations between
  3. 3 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
  4. 2 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
  5. 1 generation backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
  6. This deviceK161379 ELSA SpacersGlobus Medical, Inc. · 2016
  7. Descendant · cites it directly · 79 of its ownK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
  8. Descendant · 2 generations on · 67 of its ownK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
  9. Descendant · 2 generations on · 63 of its ownK181079 SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2018
  10. Descendant · 2 generations on · 60 of its ownK200879 SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2020
  11. Descendant · 3 generations on · 59 of its ownK192132 SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 2019 · Recalled
Show all 17 generations
  1. Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
  11. 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
  12. 6 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
  13. 5 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
  14. 4 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
  15. 3 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
  16. 2 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
  17. 1 generation backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
  18. This deviceK161379 ELSA SpacersGlobus Medical, Inc. · 2016

Showing 5 of 155 descendants. See all descendants

Descendants cleared per year

2016: 12017: 22018: 32019: 62020: 92021: 122022: 162023: 232024: 312025: 292026: 23
2016high 31 (2024) · low 1 (2016)2026

Class I recalls in this family

  • K211616 ExcelsiusHub2 generations on · 2021

Most influential descendants

Showing 5 of 155 · See all
  • K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation · 2016 · cites it directly79descendants
  • K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation · 2017 · 2 generations on67descendants
  • K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2018 · 2 generations on63descendants
  • K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2020 · 2 generations on60descendants
  • K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 2019 · 3 generations on59descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−16K990148Stackable Cage SystemDepuy Motech Acromed1999—
−15K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−14K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−13K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−12K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−11K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−10K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−9K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−8K080083Intrepid Spinal SystemMedtronic Sofamor Danek20088
−7K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008—
−6K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20081
−5K091301Life Spine Stand-Alone Spacer SystemLife Spine2009—
−4K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010—
−3K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011—
−2K141942Midline II TICentinel Spine, Inc.2014—
−1K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015—
0 (this device)K161379ELSA SpacersGlobus Medical, Inc.2016—
+1K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation2016—
+2K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura…SeaSpine Orthopedics Corporation2017—
+2K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation2018—
+2K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation2020—
+3K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation20191

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199310
199630
199820
199940
200040
2001110
2002130
2003190
2004370
2005220
2006130
2007160
2008350
2009180
2010150
2011160
201280
2013130
201460
201540

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201720
201830
201960
202090
2021121
2022160
2023230
2024310
2025290
2026230
FIG. 1 — Lineage of K161379, 1984–2026Source: 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.

1 device in this family has 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 OVD device

  1. #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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? (7)

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
*K102293Caliber Spacer
Summary page 4
…ion: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Codes: OVD, MAX Regulatory Class: Il, Panel Code: 87 Primary Predicate: CALIBER® Spacer (K102293 & K123231) Additional InterContinental® Plate-Spacer (K103382) Predicates: Centinel Spine STALIF (K150643) NuVasive CoRoent (K1…
Globus Medical, Inc.2011—
*K123231Caliber Spacers
Summary page 4
…1 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Codes: OVD, MAX Regulatory Class: Il, Panel Code: 87 Primary Predicate: CALIBER® Spacer (K102293 & K123231) Additional InterContinental® Plate-Spacer (K103382) Predicates: Centinel Spine STALIF (K150643) NuVasive CoRoent (K140479 & K1…
Globus Medical, Inc.2013—
*K103382Intercontinental Plate-Spacer
Summary page 4
…n Device Product Codes: OVD, MAX Regulatory Class: Il, Panel Code: 87 Primary Predicate: CALIBER® Spacer (K102293 & K123231) Additional InterContinental® Plate-Spacer (K103382) Predicates: Centinel Spine STALIF (K150643) NuVasive CoRoent (K140479 & K141665) Medtronic PIVOX (K152277) Purpose: The purpos…
Globus Medical, Inc.2011—
*K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
Summary page 4
…lass: Il, Panel Code: 87 Primary Predicate: CALIBER® Spacer (K102293 & K123231) Additional InterContinental® Plate-Spacer (K103382) Predicates: Centinel Spine STALIF (K150643) NuVasive CoRoent (K140479 & K141665) Medtronic PIVOX (K152277) Purpose: The purpose of this submission is to request clearance…
Centinel Spine, Inc.2015—
*K140479Coroent XL-F System
Summary page 4
…rimary Predicate: CALIBER® Spacer (K102293 & K123231) Additional InterContinental® Plate-Spacer (K103382) Predicates: Centinel Spine STALIF (K150643) NuVasive CoRoent (K140479 & K141665) Medtronic PIVOX (K152277) Purpose: The purpose of this submission is to request clearance for the ELSA™ Spacers. Dev…
Nu Vasive, Incorporated2014—
*K141665NuVasive CoRoent System
Summary page 4
…dicate: CALIBER® Spacer (K102293 & K123231) Additional InterContinental® Plate-Spacer (K103382) Predicates: Centinel Spine STALIF (K150643) NuVasive CoRoent (K140479 & K141665) Medtronic PIVOX (K152277) Purpose: The purpose of this submission is to request clearance for the ELSA™ Spacers. Device Descri…
Nuvasive, Inc.2015—
*K152277PIVOX (tm) Oblique Lateral Spinal System
Summary page 4
…102293 & K123231) Additional InterContinental® Plate-Spacer (K103382) Predicates: Centinel Spine STALIF (K150643) NuVasive CoRoent (K140479 & K141665) Medtronic PIVOX (K152277) Purpose: The purpose of this submission is to request clearance for the ELSA™ Spacers. Device Description: ELSA™ Spacers are…
Medtronic Sofamor Danek USA, Inc.2015—

Also cleared against K102293: 30 other devices →

What descends from it? (155)

See all 155

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

NumberDeviceApplicantDecidedDescendants
K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679
K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755
K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942
K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135
K181397DualXInnovasive, Inc.201815
K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228
K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196
K200338ProLift Lateral FixatedLife Spine, Inc.20205
K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213
K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250

Has anything in its family been recalled? (1 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.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 32 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
  • 27 of the 279 ancestors have a recall of any class.
  • Of its descendants, K162351 (SeaSpine Orthopedics Corporation, 2016) has gone furthest, with 79 descendants of its own.
  • 30 other devices also cite its predicate K102293.

How does its category compare?

All OVD devices

OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · OVD

10in 2025

2007: 22008: 82009: 32010: 82011: 92012: 102013: 112014: 142015: 122016: 132017: 122018: 142019: 122020: 142021: 72022: 142023: 122024: 122025: 102026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVD

100in 2025

2008: 84 days median2009: 152 days median2010: 117 days median2011: 167 days median2012: 78 days median2013: 137 days median2014: 139 days median2015: 166 days median2016: 127 days median2017: 127 days median2018: 126 days median2019: 91 days median2020: 91 days median2021: 108 days median2022: 133 days median2023: 92 days median2024: 110 days median2025: 100 days median2026 (partial year): 93 days median
2007high 167 (2011) · low 78 (2012)2026

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

Recalls per year · OVD

1in 2025

2013: 42016: 12021: 12022: 12025: 12026 (partial year): 1
2007high 4 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVD

50in 2025

2009: 22010: 22011: 62012: 162013: 172014: 352015: 432016: 552017: 722018: 1122019: 1712020: 2032021: 2212022: 742023: 672024: 922025: 50
2007high 221 (2021) · low 0 (2007)2025

MAUDE reports naming product code OVD, 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
20072—00
200888400
2009315202
2010811702
2011916706
20121078016
201311137417
201414139035
201512166043
201613127155
201712127072
2018141260112
201912910171
202014910203
202171081221
202214133174
20231292067
202412110092
202510100150
20268931—

What is it indicated for?

The ELSA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1…

Read the full statement (135 words)

The ELSA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (•20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

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 K102293

30 other devices cite the same predicate.

  • K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023
  • K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated · 2021
  • K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
  • K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
  • K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC · 2019
  • K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019

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 OVD

The OVD category page

  • K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium…INNO Holdings Inc. DBA Innovasis · 2026
  • K261408SABER-XA SystemElevation Spine · 2026
  • K261809Interwedge® Standalone LateralFoundation Surgical Group · 2026
  • K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc. · 2026
  • K260810Anteralign LS coverplateTyber Medical, LLC · 2026

https://510kreport.com/device/K161379 · printed Nov 5, 2026

Cite this page

510(k) Report. “K161379: ELSA Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161379

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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