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FDA 510(k), K051162, GENEROS SB SMALL BONE DISTRACTION IMPLANT
FDA 510(k), K051162, GENEROS SB SMALL BONE DISTRACTION IMPLANT
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510(K) Number: K051162
Device Name: GENEROS SB SMALL BONE DISTRACTION IMPLANT
Manufacturer: ORTHONETX, INC.
Device Classification Name: appliance, fixation, nail/blade/plate combination, multiple component
Regulation Number: 888.3030
Classification Product Code: KTT
Date Received: 05/05/2005
Decision Date: 07/19/2005
Regulation Medical Specialty: Orthopedic
Device Name: GENEROS SB SMALL BONE DISTRACTION IMPLANT
Manufacturer: ORTHONETX, INC.
Device Classification Name: appliance, fixation, nail/blade/plate combination, multiple component
Regulation Number: 888.3030
Classification Product Code: KTT
Date Received: 05/05/2005
Decision Date: 07/19/2005
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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