Mpres Neck Preserving Stem
K-Number: K210263 · 2021-09-22
ApplicantMedacta International S.A.
Decision Date2021-09-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Mpres Neck Preserving Stem is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-09-22 under approval number K210263. 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 Mpres Neck Preserving Stem?
Mpres Neck Preserving Stem is a medical device that received FDA 510(k) clearance on 2021-09-22. It is manufactured by Medacta International S.A.. The 510(k) number is K210263.
When was Mpres Neck Preserving Stem approved by the FDA?
Mpres Neck Preserving Stem received FDA 510(k) clearance on 2021-09-22, under approval number K210263.
What company makes Mpres Neck Preserving Stem?
Mpres Neck Preserving Stem is manufactured by Medacta International S.A..
What is the FDA product code for Mpres Neck Preserving Stem?
The FDA product code for Mpres Neck Preserving Stem 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.