prodisc® L Instruments— 510(k) K250554

Substantially Equivalent

Centinel Spine, LLC

FDA 510(k) clearance K250554 for prodisc® L Instruments, Substantially Equivalent on 2025-04-25. 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: 2025-02-25
Decision date: 2025-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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K221848 — prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments2022-08-19

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