FDA 510(k) Application Details - K233481

Device Classification Name

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510(K) Number K233481
Device Name AltiVate Reverse« Glenoid
Applicant Encore Medical, L.P.
9800 Metric Boulevard
Austin, TX 78758 US
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Contact Sherri Mellingen
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Regulation Number

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Classification Product Code PHX
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Date Received 10/26/2023
Decision Date 05/29/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233481


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