FDA 510(k) Application Details - K171624

Device Classification Name Plate, Fixation, Bone

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510(K) Number K171624
Device Name Plate, Fixation, Bone
Applicant Stuckenbrock Medizintechnik GmbH
Lessingstra▀e 50
Tuttlingen 78532 DE
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Contact Fabian Stuckenbrock
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 06/02/2017
Decision Date 03/29/2018
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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