510(k) Report

FDA applicant

Degen Medical

Florence, SC18 decisions2015–20250 recalls

FDA records 18 decisions for Degen Medical (Florence, SC) from 2015 to 2025: 18 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 63 predicates, 18 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Degen Medical, Inc.”.

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

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Degen Medical’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2015: 32016: 12018: 12019: 12020: 12021: 22022: 22023: 22024: 22025: 3
2015high 3 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Degen Medical by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Degen Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar6decisions
  • NKBThoracolumbosacral Pedicle Screw System3decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body3decisions
  • OLOOrthopedic Stereotaxic Instrument2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2decisions

How long do its 510(k) reviews take?

Since 2016, its 15 510(k)s took a median of 85 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 87 days; 7 of its 15 were faster than that.

Whose devices does it build on?

Its devices cite 63 predicates; 18 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 24 times; 18 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical · 20155cite it
  • K150759Hyper-C Anterior Cervical Plate SystemDegen Medical · 20154cite it
  • K223418DeGen Impulse AM™ SystemDegen Medical · 20232cite it
  • K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 20242cite it
  • K210090Impulse AM Interbody Fusion SystemDegen Medical · 20212cite it
  • K142531F1-Modular Pedicle Screw SystemDegen Medical · 20152cite it

What has FDA decided for it lately?

  • K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical · 2025
  • K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical · 2025
  • K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical · 2025
  • K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical · 2024
  • K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024
  • K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
  • K223418DeGen Impulse AM™ SystemDegen Medical · 2023
  • K213918DeGen Navigated InstrumentationDegen Medical · 2022

All 16 as Degen Medical →All 2 as Degen Medical, Inc. →