AMIStem-C
K-Number: K193433 · 2020-01-09
ApplicantMedacta International S.A.
Decision Date2020-01-09
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
AMIStem-C is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2020-01-09 under approval number K193433. 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-C?
AMIStem-C is a medical device that received FDA 510(k) clearance on 2020-01-09. It is manufactured by Medacta International S.A.. The 510(k) number is K193433.
When was AMIStem-C approved by the FDA?
AMIStem-C received FDA 510(k) clearance on 2020-01-09, under approval number K193433.
What company makes AMIStem-C?
AMIStem-C is manufactured by Medacta International S.A..
What is the FDA product code for AMIStem-C?
The FDA product code for AMIStem-C 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.