M6-C Artificial Cervical Disc Instruments AS— 510(k) K220861

Name: FDA 510(k) clearance K220861
Creator: U.S. Food and Drug Administration
Published: 2022-06-02

Substantially Equivalent

Spinal Kinetics, LLC

FDA 510(k) clearance K220861 for M6-C Artificial Cervical Disc Instruments AS, Substantially Equivalent on 2022-06-02. Applicant: Spinal Kinetics, LLC. Device class: 2.

Clearance details

Applicant: Spinal Kinetics, LLC
Product code: Code QLQ
Device class: Class 2
Regulation: 21 CFR 888.4515
Advisory panel: Orthopedic
Date received: 2022-03-24
Decision date: 2022-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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