prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments— 510(k) K221848

Name: FDA 510(k) clearance K221848
Creator: U.S. Food and Drug Administration
Published: 2022-08-19

Substantially Equivalent

Centinel Spine, LLC

FDA 510(k) clearance K221848 for prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments, Substantially Equivalent on 2022-08-19. Applicant: Centinel Spine, LLC. Device class: 2.

Clearance details

Applicant: Centinel Spine, LLC
Product code: Code QLQ
Device class: Class 2
Regulation: 21 CFR 888.4515
Advisory panel: Orthopedic
Date received: 2022-06-24
Decision date: 2022-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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