FDA 510(k) Application Details - K230764

Device Classification Name Device, Fixation, Proximal Femoral, Implant

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510(K) Number K230764
Device Name Device, Fixation, Proximal Femoral, Implant
Applicant OsteoCentric Technologies
75 West 300 North
Suite 150
Logan, UT 84321 US
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Contact Todd Evans
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Regulation Number 888.3030

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Classification Product Code JDO
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Date Received 03/20/2023
Decision Date 04/18/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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