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FDA 510(k), K133036, APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
FDA 510(k), K133036, APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
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510(K) Number: K133036
Device Name: APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
Manufacturer: RICH JANSEN
Device Classification Name: Fastener, Fixation, Nondegradable, Soft Tissue
Regulation Number: MBI
Classification Product Code: 09/26/2013
Date Received: 03/06/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
Manufacturer: RICH JANSEN
Device Classification Name: Fastener, Fixation, Nondegradable, Soft Tissue
Regulation Number: MBI
Classification Product Code: 09/26/2013
Date Received: 03/06/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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