FDA 510(k) Application Details - K240876

Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

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510(K) Number K240876
Device Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Applicant Zimmer Inc.
1800 West Center St.
Warsaw, IN 46580 US
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Contact Patricia Beres
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Regulation Number 888.3670

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Classification Product Code MBF
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Date Received 03/29/2024
Decision Date 06/12/2024
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 K240876


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