PolyLock Small Bone Plating System
K-Number: K192323 · 2019-11-18
ApplicantFusion Orthopedics, LLC
Decision Date2019-11-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PolyLock Small Bone Plating System is a medical device manufactured by Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2019-11-18 under approval number K192323. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PolyLock Small Bone Plating System?
PolyLock Small Bone Plating System is a medical device that received FDA 510(k) clearance on 2019-11-18. It is manufactured by Fusion Orthopedics, LLC. The 510(k) number is K192323.
When was PolyLock Small Bone Plating System approved by the FDA?
PolyLock Small Bone Plating System received FDA 510(k) clearance on 2019-11-18, under approval number K192323.
What company makes PolyLock Small Bone Plating System?
PolyLock Small Bone Plating System is manufactured by Fusion Orthopedics, LLC.
What is the FDA product code for PolyLock Small Bone Plating System?
The FDA product code for PolyLock Small Bone Plating System is HRS.
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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.