510(k) Report

FDA applicant

Flospine

Boca Raton, FL5 decisions2014–20230 recalls

FDA records 5 decisions for Flospine (Boca Raton, FL) from 2014 to 2023: 5 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and PEK (Spinous Process Plate). Since 2016 its 510(k)s took a median of 79 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Flospine, LLC”.

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 Flospine’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2014: 12020: 12021: 12023: 2
2014high 2 (2023) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Flospine by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • PEKSpinous Process Plate1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 79 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193255Largo PEEK Interbody SystemFlospine, LLC · 20201cites it

What has FDA decided for it lately?

  • K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine · 2023
  • K223231Ti-Largo Cervical Interbody SystemFlospine · 2023
  • K210182PANAMA™ Anterior Cervical Plate (ACP) SystemFlospine · 2021
  • K193255Largo PEEK Interbody SystemFlospine, LLC · 2020
  • K141850Flospine Pedicle Screw SystemFlospine · 2014

All 4 as Flospine →The one decision as Flospine, LLC →