FDA applicant

Synergy Spine Solutions, Inc.

Louisville, CO2 decisions2026–20260 recalls

FDA records 2 decisions for Synergy Spine Solutions, Inc. (Louisville, CO) in 2026: 1 510(k) clearance and 1 original PMA approval. Most are in product codes QLQ (Manual Instruments Designed For Use With Total…) and MJO (Prosthesis, Intervertebral Disc). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

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 Synergy Spine Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2026

2026high 2 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

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Other applicant names beginning “Synergy”

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

Synergy Biomedical 5 Synergy Orthopaedics Intl., Inc. 2 Synergy Surgical Technologies, LLC 1

Synergy Spine Solutions, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Synergy”