FDA 510(k) Application Details - K241014

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K241014
Device Name Pin, Fixation, Smooth
Applicant Biomet, Inc
56 East Bell Drive
P.O. Box 587
Warsaw, IN 46581 US
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Contact Akash Savalia
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 04/12/2024
Decision Date 05/22/2024
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 K241014


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