COPAL exchange G Hip and Knee Spacers
K-Number: K191016 · 2019-11-01
ApplicantHeraeus Medical GmbH
Decision Date2019-11-01
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
COPAL exchange G Hip and Knee Spacers is a medical device manufactured by Heraeus Medical GmbH. It received FDA 510(k) clearance on 2019-11-01 under approval number K191016. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the COPAL exchange G Hip and Knee Spacers?
COPAL exchange G Hip and Knee Spacers is a medical device that received FDA 510(k) clearance on 2019-11-01. It is manufactured by Heraeus Medical GmbH. The 510(k) number is K191016.
When was COPAL exchange G Hip and Knee Spacers approved by the FDA?
COPAL exchange G Hip and Knee Spacers received FDA 510(k) clearance on 2019-11-01, under approval number K191016.
What company makes COPAL exchange G Hip and Knee Spacers?
COPAL exchange G Hip and Knee Spacers is manufactured by Heraeus Medical GmbH.
What is the FDA product code for COPAL exchange G Hip and Knee Spacers?
The FDA product code for COPAL exchange G Hip and Knee Spacers is KWY.
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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.