3DMetal Tibial Cones
K-Number: K170149 · 2017-08-18
ApplicantMedacta International S.A.
Decision Date2017-08-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
3DMetal Tibial Cones is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2017-08-18 under approval number K170149. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 3DMetal Tibial Cones?
3DMetal Tibial Cones is a medical device that received FDA 510(k) clearance on 2017-08-18. It is manufactured by Medacta International S.A.. The 510(k) number is K170149.
When was 3DMetal Tibial Cones approved by the FDA?
3DMetal Tibial Cones received FDA 510(k) clearance on 2017-08-18, under approval number K170149.
What company makes 3DMetal Tibial Cones?
3DMetal Tibial Cones is manufactured by Medacta International S.A..
What is the FDA product code for 3DMetal Tibial Cones?
The FDA product code for 3DMetal Tibial Cones is JWH.
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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.