Cartiva SCI Disposable Instrumentation Set— 510(k) K181348

Name: FDA 510(k) clearance K181348
Creator: U.S. Food and Drug Administration
Published: 2018-06-20

Substantially Equivalent

Cartiva, Inc.

FDA 510(k) clearance K181348 for Cartiva SCI Disposable Instrumentation Set, Substantially Equivalent on 2018-06-20. Applicant: Cartiva, Inc.. Device class: 2.

Clearance details

Applicant: Cartiva, Inc.
Product code: Code QBO
Device class: Class 2
Regulation: 21 CFR 888.4505
Advisory panel: Orthopedic
Date received: 2018-05-21
Decision date: 2018-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

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