COPAL exchange G hip spacer
K-Number: K220492 · 2022-03-23
ApplicantHeraeus Medical GmbH
Decision Date2022-03-23
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
COPAL exchange G hip spacer is a medical device manufactured by Heraeus Medical GmbH. It received FDA 510(k) clearance on 2022-03-23 under approval number K220492. 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 spacer?
COPAL exchange G hip spacer is a medical device that received FDA 510(k) clearance on 2022-03-23. It is manufactured by Heraeus Medical GmbH. The 510(k) number is K220492.
When was COPAL exchange G hip spacer approved by the FDA?
COPAL exchange G hip spacer received FDA 510(k) clearance on 2022-03-23, under approval number K220492.
What company makes COPAL exchange G hip spacer?
COPAL exchange G hip spacer is manufactured by Heraeus Medical GmbH.
What is the FDA product code for COPAL exchange G hip spacer?
The FDA product code for COPAL exchange G hip spacer 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.