FDA 510(k) Application Details - K241282

Device Classification Name Plate, Fixation, Bone

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510(K) Number K241282
Device Name Plate, Fixation, Bone
Applicant Riverpoint Medical
825 NE 25th Ave
Portland, OR 97232 US
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Contact Paul Vagts
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 05/07/2024
Decision Date 08/19/2024
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 K241282


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