prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments— 510(k) K263159

Name: FDA 510(k) clearance K263159
Creator: U.S. Food and Drug Administration
Published: 2026-10-07

Substantially Equivalent

Centinel Spine, LLC

FDA 510(k) clearance K263159 for prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments, Substantially Equivalent on 2026-10-07. Applicant: Centinel Spine, LLC. Device class: 2.

Summary

Centinel Spine's clearance lists prodisc C, prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments. Product code QLQ is manual instruments designed for use with total disc replacement devices, so the clearance appears to cover instruments rather than the disc implants themselves. The record doesn't break this out further.

Class II, 21 CFR 888.4515. The Orthopedic panel reviewed it as a Special 510(k).

Centinel Spine filed from West Chester, Pennsylvania. Review took 28 days (September 9 to October 7, 2026).

Clearance details

Applicant: Centinel Spine, LLC
Product code: Product code QLQ
Device class: Class 2
Regulation: 21 CFR 888.4515
Advisory panel: Orthopedic
Date received: 2026-09-09
Decision date: 2026-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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