M6-C Single Use, Disposable Instrumentation— 510(k) K241117

Name: FDA 510(k) clearance K241117
Creator: U.S. Food and Drug Administration
Published: 2024-06-21

Substantially Equivalent

Spinal Kinetics / Orthofix / Seaspine

FDA 510(k) clearance K241117 for M6-C Single Use, Disposable Instrumentation, Substantially Equivalent on 2024-06-21. Applicant: Spinal Kinetics / Orthofix / Seaspine. Device class: 2.

Clearance details

Applicant: Spinal Kinetics / Orthofix / Seaspine
Product code: Code QLQ
Device class: Class 2
Regulation: 21 CFR 888.4515
Advisory panel: Orthopedic
Date received: 2024-04-23
Decision date: 2024-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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