FDA 510(k), K142292, Speed, Speed Shift, Speed Titan, Speed Arc
FDA 510(k), K142292, Speed, Speed Shift, Speed Titan, Speed Arc
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$149.00 USD
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510(K) Number: K142292
Device Name: Speed, Speed Shift, Speed Titan, Speed Arc
Manufacturer: BioMedical Enterprises, Inc.
Device Classification Name: staple, fixation, bone
Regulation Number: 888.3030
Classification Product Code: JDR
Date Received: 08/18/2014
Decision Date: 11/17/2014
Regulation Medical Specialty: Orthopedic
Device Name: Speed, Speed Shift, Speed Titan, Speed Arc
Manufacturer: BioMedical Enterprises, Inc.
Device Classification Name: staple, fixation, bone
Regulation Number: 888.3030
Classification Product Code: JDR
Date Received: 08/18/2014
Decision Date: 11/17/2014
Regulation Medical Specialty: Orthopedic
- 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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