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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 the device name listed in this FDA 510(k) record. The listed applicant is Synergy Spine Solutions, Inc.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) 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. The listed applicant is Synergy Spine Solutions, Inc.. The 510(k) number is K253392.

When did Synergy Disc Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for Synergy Disc Instruments?

The FDA 510(k) record lists Synergy Spine Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synergy Disc Instruments?

The FDA product code for Synergy Disc Instruments is QLQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05740176The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion SurgeryACTIVE_NOT_RECRUITINGNCT05305430Real World Data Collection on the Synergy Cervical DiscRECRUITINGNCT05880823Post Market Data Collection Protocol to Evaluate the Performance of the Synergy DiscWITHDRAWNNCT06383962Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®RECRUITING

Other records listing Synergy Spine Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P250028Prosthesis, intervertebral disc

Related Devices (Code: QLQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262639BAGUERA® C Cervical Disc Surgical InstrumentsSpineart SAK250554prodisc® L InstrumentsCentinel Spine, LLCK242869prodisc® L InstrumentsCentinel Spine, LLCK241117M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / SeaspineK231769activL® Next Generation InstrumentationAesculap Implants Systems, LLCK221848prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC

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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