FDA applicant

Bright Spine

Boca Raton, FL3 decisions2011–20230 recalls

FDA records 3 decisions for Bright Spine (Boca Raton, FL) from 2011 to 2023: 3 510(k) clearances. Most are in product codes PLR (Spinal Vertebral Body Replacement Device -…) and ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bright Spine, 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 Bright Spine’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Bright Spine by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bright Spine’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

Other applicant names beginning “Bright”

FDA records each applicant name separately; these may or may not be the same firm.

Bright Element Sdn Bhd 4 Bright Uro, Inc. 2 Bright Rubber Industries Private, Ltd. 1 Bright Medical Instruments 1 Bright Horizon Ent. 1

Bright Spine

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Bright”