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.

Summary

Synergy Spine Solutions' Synergy Disc Instruments are filed under QLQ, manual instruments designed for use with total disc replacement devices. The record doesn't list the individual instruments.

Class II, 21 CFR 888.4515. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Synergy Spine Solutions filed from Louisville, Colorado. Review took 178 calendar days (September 30, 2025 to March 27, 2026).

Clearance details

Applicant: Synergy Spine Solutions, Inc.
Product code: Product 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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