FDA 510(k) Application Details - K242302

Device Classification Name Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

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510(K) Number K242302
Device Name Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Applicant Collagen Matrix, Inc.
15 Thornton Road
Oakland, NJ 07436 US
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Contact Devin Dragon
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Regulation Number 878.3300

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Classification Product Code OLC
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Date Received 08/05/2024
Decision Date 10/02/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242302


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