510(k) Report

510(k) · Cleared

Cleared

APEX-DL Spine System

K143683510(k) TraditionalCleared May 22, 2015149-day reviewClass II21 CFR 888.3070

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

Spinecraft, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on May 22, 2015 as substantially equivalent to K142185 (Depuy Spine, Inc., 2014) and 16 other predicates after a 149-day review. Its family tree reaches back 12 generations to 1999. 3 later devices descend from it.

Decided
May 22, 2015
Review
149 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
17

Its longest line of descent runs back 12 generations to K990745 (1999). 201 ancestors in all, the oldest K781443 (1978). 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2012: 3 other ancestors2010: 8 other ancestors2009: 7 other ancestors2008: 11 other ancestors2007: 6 other ancestors2006: 11 other ancestors2000: 17 other ancestors1998: 14 other ancestors1997: 7 other ancestors1995: 7 other ancestors2011: 2 other ancestors2005: 12 other ancestors2004: 15 other ancestors2003: 12 other ancestors2002: 10 other ancestors2001: 15 other ancestors1996: 8 other ancestors1994: 3 other ancestors1993: 3 other ancestors1992: 5 other ancestors1990: 2 other ancestors1978: 1 other ancestor1999: 8 other ancestors1985: 1 other ancestor2021: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK990745 · Modification to Synthes Universal Spinal System · Synthes Spine · 1999K992739 · Click'x · Synthes Spine · 2000 · recalledK040442 · Protex Stabilization System · Globus Medical, Inc. · 2004K052069 · Protex Stabilization System with Additional Componentes · Globus Medical, Inc. · 2005K061202 · Revere Stabilization System · Globus Medical, Inc. · 2006K081195 · Revere Uniplanar Screws · Globus Medical, Inc. · 2008×3: 3 generations cleared close together, K091782 (2009), K093294 (2010), K100788 (2010) K102488 · Apex Spine System W/ Cocr Rods · Spinecraft, LLC · 2010K110906 · Apex Spine System · Spinecraft, LLC · 2011K132603 · Apex Spine System · Spinecraft, LLC · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 14 other ancestors2 generations back: 51 other ancestors3 generations back: 36 other ancestors4 generations back: 39 other ancestors5 generations back: 25 other ancestors6 generations back: 16 other ancestors7 generations back: 8 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K132603 · Apex Spine System · Spinecraft, LLC · 2013K110906 · Apex Spine System · Spinecraft, LLC · 2011K102488 · Apex Spine System W/ Cocr Rods · Spinecraft, LLC · 2010K100788 · Cocr Rods · Globus Medical, Inc. · 2010K093294 · Revere Stabilization System · Globus Medical, Inc. · 2010K091782 · Revere 6.35 Stabilization System · Globus Medical, Inc. · 2009K081195 · Revere Uniplanar Screws · Globus Medical, Inc. · 2008K061202 · Revere Stabilization System · Globus Medical, Inc. · 2006K052069 · Protex Stabilization System with Additional Componentes · Globus Medical, Inc. · 2005K040442 · Protex Stabilization System · Globus Medical, Inc. · 2004K992739 · Click'x · Synthes Spine · 2000 · recalledK990745 · Modification to Synthes Universal Spinal System · Synthes Spine · 1999−10−50
  1. Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
  2. 8 generations between
  3. 3 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
  4. 2 generations backK110906 Apex Spine SystemSpinecraft, LLC · 2011
  5. 1 generation backK132603 Apex Spine SystemSpinecraft, LLC · 2013
  6. This deviceK143683 APEX-DL Spine SystemSpinecraft, LLC · 2015
  7. Descendant · cites it directly · 1 of its ownK234048 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024
  8. Descendant · 2 generations on · 0 of its ownK253940 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026
  9. Descendant · cites it directly · 0 of its ownK211935 ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
Show all 12 generations
  1. Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
  2. 11 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
  3. 10 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
  4. 9 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
  5. 8 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
  6. 7 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
  7. 6 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
  8. 5 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
  9. 4 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
  10. 3 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
  11. 2 generations backK110906 Apex Spine SystemSpinecraft, LLC · 2011
  12. 1 generation backK132603 Apex Spine SystemSpinecraft, LLC · 2013
  13. This deviceK143683 APEX-DL Spine SystemSpinecraft, LLC · 2015

Most influential descendants

Showing 3 of 3 · See all
  • K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024 · cites it directly1descendant
  • K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026 · 2 generations on0descendants
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K990745Modification to Synthes Universal Spinal SystemSynthes Spine1999—
−11K992739Click'xSynthes Spine20001
−10K040442Protex Stabilization SystemGlobus Medical, Inc.2004—
−9K052069Protex Stabilization System with Additional ComponentesGlobus Medical, Inc.2005—
−8K061202Revere Stabilization SystemGlobus Medical, Inc.2006—
−7K081195Revere Uniplanar ScrewsGlobus Medical, Inc.2008—
−6K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009—
−5K093294Revere Stabilization SystemGlobus Medical, Inc.2010—
−4K100788Cocr RodsGlobus Medical, Inc.2010—
−3K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010—
−2K110906Apex Spine SystemSpinecraft, LLC2011—
−1K132603Apex Spine SystemSpinecraft, LLC2013—
0 (this device)K143683APEX-DL Spine SystemSpinecraft, LLC2015—
+1K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.2024—
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.2026—
+1K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198510
199020
199250
199330
199430
199570
199680
199770
1998140
199980
2000170
2001150
2002100
2003120
2004150
2005120
2006110
200760
2008110
200970
201080
201120
201230
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202410
202610
FIG. 1 — Lineage of K143683, 1999–2026Source: 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.

Planning a device in NKB? 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 NKB device

  1. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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? (17)

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
*K142185Expedium Verse Spine System
Summary page 4
…interlaminal fixation orthosis per KWP 888.3050 3. Primary predicate or legally marketed device which is substantially equivalent: x EXPEDIUM Verse Spine System (K142185) DePuy Synthes Spine 4. Secondary predicate devices: x Viper Spine System (K090648 / K102701) DePuy Spine x APEX Spin…
Depuy Spine, Inc.2014—
*K090648Viper 2 System
Summary page 4
…device which is substantially equivalent: x EXPEDIUM Verse Spine System (K142185) DePuy Synthes Spine 4. Secondary predicate devices: x Viper Spine System (K090648 / K102701) DePuy Spine x APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft x Xia Spinal Sy…
Depuy Spine, Inc.2009—
*K102701Viper Spine System
Summary page 4
…ich is substantially equivalent: x EXPEDIUM Verse Spine System (K142185) DePuy Synthes Spine 4. Secondary predicate devices: x Viper Spine System (K090648 / K102701) DePuy Spine x APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft x Xia Spinal System (K113…
Depuy Spine, Inc.2010—
*K062513Apex Spine System
Summary page 4
…UM Verse Spine System (K142185) DePuy Synthes Spine 4. Secondary predicate devices: x Viper Spine System (K090648 / K102701) DePuy Spine x APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft x Xia Spinal System (K113666 / K071373 / K060748) Stryker x SPINE-T…
Spinecraft, Inc.2006—
*K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer
Summary page 4
…pine System (K142185) DePuy Synthes Spine 4. Secondary predicate devices: x Viper Spine System (K090648 / K102701) DePuy Spine x APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft x Xia Spinal System (K113666 / K071373 / K060748) Stryker x SPINE-TECH SILHOU…
Spinecraft, Inc.2010—
*K102488Apex Spine System W/ Cocr Rods
Summary page 4
…m (K142185) DePuy Synthes Spine 4. Secondary predicate devices: x Viper Spine System (K090648 / K102701) DePuy Spine x APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft x Xia Spinal System (K113666 / K071373 / K060748) Stryker x SPINE-TECH SILHOUETTE SPINA…
Spinecraft, LLC2010—
*K110906Apex Spine System
Summary page 4
…) DePuy Synthes Spine 4. Secondary predicate devices: x Viper Spine System (K090648 / K102701) DePuy Spine x APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft x Xia Spinal System (K113666 / K071373 / K060748) Stryker x SPINE-TECH SILHOUETTE SPINAL FIXATION…
Spinecraft, LLC2011—
*K132603Apex Spine System
Summary page 4
…nthes Spine 4. Secondary predicate devices: x Viper Spine System (K090648 / K102701) DePuy Spine x APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft x Xia Spinal System (K113666 / K071373 / K060748) Stryker x SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM (K…
Spinecraft, LLC2013—
*K113666Xia 3 Spinal System
Summary page 4
…x Viper Spine System (K090648 / K102701) DePuy Spine x APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft x Xia Spinal System (K113666 / K071373 / K060748) Stryker x SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM (K980288) SPINE-TECH, INC x MOSS MIAMI SS (…
Stryker Spine2012—
*K071373Stryker Spine Xia Iii Spinal System
Summary page 4
…er Spine System (K090648 / K102701) DePuy Spine x APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft x Xia Spinal System (K113666 / K071373 / K060748) Stryker x SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM (K980288) SPINE-TECH, INC x MOSS MIAMI SS (K950697 /…
Stryker Spine20071
*K060748Modification to Xia 4.5 Spinal System
Summary page 4
…ystem (K090648 / K102701) DePuy Spine x APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft x Xia Spinal System (K113666 / K071373 / K060748) Stryker x SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM (K980288) SPINE-TECH, INC x MOSS MIAMI SS (K950697 / K000536) D…
Stryker Spine2006—
*K980288Spine-Tech Silhouette Spinal Fixation System
Summary page 4
…3 / K092825 / K102488 / K110906 / K132603) SpineCraft x Xia Spinal System (K113666 / K071373 / K060748) Stryker x SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM (K980288) SPINE-TECH, INC x MOSS MIAMI SS (K950697 / K000536) DePuy Spine x Synergy VLS – open – (K940631 / K950099) Cross Medic…
Spine-Tech, Inc.1998—
*K950697Depuy Motech Moss Miami Spinal System - Pedicle Fixation
Summary page 4
…eCraft x Xia Spinal System (K113666 / K071373 / K060748) Stryker x SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM (K980288) SPINE-TECH, INC x MOSS MIAMI SS (K950697 / K000536) DePuy Spine x Synergy VLS – open – (K940631 / K950099) Cross Medical x Ti Expedium 4.5 Spine System (K081252…
Depuy Motech1995—
*K000536Synthes Anterior CSLP System
Summary page 4
…x Xia Spinal System (K113666 / K071373 / K060748) Stryker x SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM (K980288) SPINE-TECH, INC x MOSS MIAMI SS (K950697 / K000536) DePuy Spine x Synergy VLS – open – (K940631 / K950099) Cross Medical x Ti Expedium 4.5 Spine System (K081252) DePuy Sp…
Synthes Spine20001
*K940631Cross Medical - Synergy (TM) Spine System
Summary page 4
…) Stryker x SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM (K980288) SPINE-TECH, INC x MOSS MIAMI SS (K950697 / K000536) DePuy Spine x Synergy VLS – open – (K940631 / K950099) Cross Medical x Ti Expedium 4.5 Spine System (K081252) DePuy Spine 5. Description of the device: The APE…
Cross Medical Products, Inc.1995—
*K950099Synergy (TM) TI Posterior Spinal System
Summary page 4
…x SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM (K980288) SPINE-TECH, INC x MOSS MIAMI SS (K950697 / K000536) DePuy Spine x Synergy VLS – open – (K940631 / K950099) Cross Medical x Ti Expedium 4.5 Spine System (K081252) DePuy Spine 5. Description of the device: The APEX-DL Spine…
Buckman Co., Inc.1997—
*K081252Expedium 4.5MM Spine System
Summary page 4
…) SPINE-TECH, INC x MOSS MIAMI SS (K950697 / K000536) DePuy Spine x Synergy VLS – open – (K940631 / K950099) Cross Medical x Ti Expedium 4.5 Spine System (K081252) DePuy Spine 5. Description of the device: The APEX-DL Spine System includes Monoaxial, Uniplanar, and Polyaxial Double…
Depuy Spine, Inc.2008—

Also cleared against K142185: 3 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241
K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • 15 of the 201 ancestors have a recall of any class.
  • Of its descendants, K234048 (Medacta International S.A., 2024) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K142185.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

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

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The APEX-DL Spine System with APEX Spine System Components is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment…

Read the full statement (353 words)

The APEX-DL Spine System with APEX Spine System Components is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX-DL Spine System with APEX Spine System Components is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The APEX-DL Spine System with APEX Spine System Components is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous posterior approach with AIM MIS instrumentation, the APEX-DL Spine System with APEX Spine System Components is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the APEX-DL Spine System implants with APEX Spine System Components are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The APEX DL Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Indications for use as stated in the FDA summary.

Also cleared against K142185

3 other devices cite the same predicate.

  • K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl · 2020
  • K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020
  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019

More from Spinecraft, LLC

12 FDA decisions under this applicant name. See the company

  • K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC · 2023
  • K223273ASTRA Spine SystemSpinecraft, LLC · 2022
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
  • K211323ASTRA Spine SystemSpinecraft, LLC · 2021
  • K181350ASTRA-OCT Spine SystemSpinecraft, LLC · 2018

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K143683 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143683: APEX-DL Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143683

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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