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FDA 510(k), K170364, Collagen Meniscus Implant XL
FDA 510(k), K170364, Collagen Meniscus Implant XL
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$149.00 USD
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510(K) Number: K170364
Device Name: Collagen Meniscus Implant XL
Manufacturer: John Dichiara
Device Classification Name: Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Regulation Number: OLC
Classification Product Code: 02/06/2017
Date Received: 05/02/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: Collagen Meniscus Implant XL
Manufacturer: John Dichiara
Device Classification Name: Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Regulation Number: OLC
Classification Product Code: 02/06/2017
Date Received: 05/02/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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