FDA applicant

Sapphire Medical Group

Dana Point, CA5 decisions2012–20240 recalls

FDA records 5 decisions for Sapphire Medical Group (Dana Point, CA) from 2012 to 2024: 5 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Since 2016 its 510(k)s took a median of 78 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sapphire Medical Group, 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 Sapphire Medical Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2012high 2 (2019) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Sapphire Medical Group by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sapphire Medical Group’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 “Sapphire”

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

Sapphire Medical, Inc. 1

Sapphire Medical Group

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Sapphire”