FDA 510(k) Application Details - K233712

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

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510(K) Number K233712
Device Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Applicant LimaCorporate S.p.A
Via Nazionale, 52
Villanova di San Daniele del Friuli 33038 IT
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Contact Michela Zanotto
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Regulation Number 888.3670

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Classification Product Code MBF
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Date Received 11/20/2023
Decision Date 01/11/2024
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 K233712


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