BC Reflex Uni Knee System
K-Number: K191996 · 2019-12-05
ApplicantBodycad Laboratories, Inc.
Decision Date2019-12-05
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
BC Reflex Uni Knee System is a medical device manufactured by Bodycad Laboratories, Inc.. It received FDA 510(k) clearance on 2019-12-05 under approval number K191996. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BC Reflex Uni Knee System?
BC Reflex Uni Knee System is a medical device that received FDA 510(k) clearance on 2019-12-05. It is manufactured by Bodycad Laboratories, Inc.. The 510(k) number is K191996.
When was BC Reflex Uni Knee System approved by the FDA?
BC Reflex Uni Knee System received FDA 510(k) clearance on 2019-12-05, under approval number K191996.
What company makes BC Reflex Uni Knee System?
BC Reflex Uni Knee System is manufactured by Bodycad Laboratories, Inc..
What is the FDA product code for BC Reflex Uni Knee System?
The FDA product code for BC Reflex Uni Knee System is HSX.
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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.