Fusion Silastic System
K-Number: K190136 · 2019-10-21
ApplicantFusion Orthopedics, LLC
Decision Date2019-10-21
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Fusion Silastic System is a medical device manufactured by Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2019-10-21 under approval number K190136. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Fusion Silastic System?
Fusion Silastic System is a medical device that received FDA 510(k) clearance on 2019-10-21. It is manufactured by Fusion Orthopedics, LLC. The 510(k) number is K190136.
When was Fusion Silastic System approved by the FDA?
Fusion Silastic System received FDA 510(k) clearance on 2019-10-21, under approval number K190136.
What company makes Fusion Silastic System?
Fusion Silastic System is manufactured by Fusion Orthopedics, LLC.
What is the FDA product code for Fusion Silastic System?
The FDA product code for Fusion Silastic System is KWH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.