MSS - Monobloc stem
K-Number: K250644 · 2026-02-03
ApplicantMedacta International S.A.
Decision Date2026-02-03
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MSS - Monobloc stem is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2026-02-03 under approval number K250644. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MSS - Monobloc stem?
MSS - Monobloc stem is a medical device that received FDA 510(k) clearance on 2026-02-03. It is manufactured by Medacta International S.A.. The 510(k) number is K250644.
When was MSS - Monobloc stem approved by the FDA?
MSS - Monobloc stem received FDA 510(k) clearance on 2026-02-03, under approval number K250644.
What company makes MSS - Monobloc stem?
MSS - Monobloc stem is manufactured by Medacta International S.A..
What is the FDA product code for MSS - Monobloc stem?
The FDA product code for MSS - Monobloc stem is PHX.
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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.