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FDA 510(k), K143350, Nile Alternative Fixation
FDA 510(k), K143350, Nile Alternative Fixation
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$149.00 USD
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510(K) Number: K143350
Device Name: Nile Alternative Fixation
Manufacturer: K2M, Inc.
Device Classification Name: bone fixation cerclage, sublaminar
Regulation Number: 888.3010
Classification Product Code: OWI
Date Received: 11/24/2014
Decision Date: 02/25/2015
Regulation Medical Specialty: Orthopedic
Device Name: Nile Alternative Fixation
Manufacturer: K2M, Inc.
Device Classification Name: bone fixation cerclage, sublaminar
Regulation Number: 888.3010
Classification Product Code: OWI
Date Received: 11/24/2014
Decision Date: 02/25/2015
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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