BAGUERA® C Cervical Disc Surgical Instruments— 510(k) K262639

Name: FDA 510(k) clearance K262639
Creator: U.S. Food and Drug Administration
Published: 2026-08-14

Substantially Equivalent

Spineart SA

FDA 510(k) clearance K262639 for BAGUERA® C Cervical Disc Surgical Instruments, Substantially Equivalent on 2026-08-14. Applicant: Spineart SA. Device class: 2.

Summary

Spineart's BAGUERA C Cervical Disc Surgical Instruments are filed under product code QLQ, manual instruments designed for use with total disc replacement devices. The record doesn't list individual instruments.

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

Spineart filed from Plan-Les-Ouates, Switzerland. Review took 16 calendar days (July 29 to August 14, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant: Spineart SA
Product code: Product code QLQ
Device class: Class 2
Regulation: 21 CFR 888.4515
Advisory panel: Orthopedic
Date received: 2026-07-29
Decision date: 2026-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plan-Les-Ouates, CH

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.