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FDA 510(k)

BAGUERA® C Cervical Disc Surgical Instruments

K-Number: K262639 · 2026-08-14

ApplicantSpineart SA
Decision Date2026-08-14
Product CodeQLQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BAGUERA® C Cervical Disc Surgical Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Spineart SA. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K262639. 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 BAGUERA® C Cervical Disc Surgical Instruments?

BAGUERA® C Cervical Disc Surgical Instruments is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Spineart SA. The 510(k) number is K262639.

When did BAGUERA® C Cervical Disc Surgical Instruments receive FDA 510(k) clearance?

BAGUERA® C Cervical Disc Surgical Instruments received FDA 510(k) clearance on 2026-08-14, under 510(k) number K262639.

Who is the listed applicant for BAGUERA® C Cervical Disc Surgical Instruments?

The FDA 510(k) record lists Spineart SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAGUERA® C Cervical Disc Surgical Instruments?

The FDA product code for BAGUERA® C Cervical Disc Surgical Instruments is QLQ.

Other records listing Spineart SA as applicant

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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.

K253392Synergy Disc InstrumentsSynergy Spine Solutions, Inc.K250554prodisc® 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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