FDA 510(k) Application Details - K203475

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K203475
Device Name Pin, Fixation, Smooth
Applicant Limacorporate S.p.A.
Via Nazionale, 52
Villanova di San Daniele 33038 IT
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Contact Ilaria Giannuzzi
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 11/25/2020
Decision Date 02/05/2021
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



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