AMIStem-H Proximal Coating
K-Number: K161635 · 2017-03-31
ApplicantMedacta International S.A.
Decision Date2017-03-31
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
AMIStem-H Proximal Coating is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2017-03-31 under approval number K161635. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AMIStem-H Proximal Coating?
AMIStem-H Proximal Coating is a medical device that received FDA 510(k) clearance on 2017-03-31. It is manufactured by Medacta International S.A.. The 510(k) number is K161635.
When was AMIStem-H Proximal Coating approved by the FDA?
AMIStem-H Proximal Coating received FDA 510(k) clearance on 2017-03-31, under approval number K161635.
What company makes AMIStem-H Proximal Coating?
AMIStem-H Proximal Coating is manufactured by Medacta International S.A..
What is the FDA product code for AMIStem-H Proximal Coating?
The FDA product code for AMIStem-H Proximal Coating is LZO.
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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.