Fusion Silastic System— 510(k) K190136

Substantially Equivalent

Fusion Orthopedics, LLC

FDA 510(k) clearance K190136 for Fusion Silastic System, Substantially Equivalent on 2019-10-21. Applicant: Fusion Orthopedics, LLC.

Clearance details

Applicant: Fusion Orthopedics, LLC
Product code: Code KWH
Advisory panel: Orthopedic
Date received: 2019-01-29
Decision date: 2019-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mesa, AZ, US

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