Synergy Disc Instruments— 510(k) K253392

Name: FDA 510(k) clearance K253392
Creator: U.S. Food and Drug Administration
Published: 2026-03-27

Substantially Equivalent

Synergy Spine Solutions, Inc.

FDA 510(k) clearance K253392 for Synergy Disc Instruments, Substantially Equivalent on 2026-03-27. Applicant: Synergy Spine Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Synergy Spine Solutions, Inc.
Product code: Code QLQ
Device class: Class 2
Regulation: 21 CFR 888.4515
Advisory panel: Orthopedic
Date received: 2025-09-30
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

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