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FDA 510(k)

Synergy Disc Instruments

K-Number: K253392 · 2026-03-27

ApplicantSynergy Spine Solutions, Inc.
Decision Date2026-03-27
Product CodeQLQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Synergy Disc Instruments is a medical device manufactured by Synergy Spine Solutions, Inc.. It received FDA 510(k) clearance on 2026-03-27 under approval number K253392. The device is classified under product code QLQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synergy Disc Instruments?

Synergy Disc Instruments is a medical device that received FDA 510(k) clearance on 2026-03-27. It is manufactured by Synergy Spine Solutions, Inc.. The 510(k) number is K253392.

When was Synergy Disc Instruments approved by the FDA?

Synergy Disc Instruments received FDA 510(k) clearance on 2026-03-27, under approval number K253392.

What company makes Synergy Disc Instruments?

Synergy Disc Instruments is manufactured by Synergy Spine Solutions, Inc..

What is the FDA product code for Synergy Disc Instruments?

The FDA product code for Synergy Disc Instruments is QLQ.

Other Devices by Synergy Spine Solutions, Inc.

PMA P250028Prosthesis, intervertebral disc

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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