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FDA 510(k), K063857, SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
FDA 510(k), K063857, SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
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510(K) Number: K063857
Device Name: SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
Manufacturer: TIFFANI ROGERS
Device Classification Name: Bone Cement, Antibiotic
Regulation Number: MBB
Classification Product Code: 12/28/2006
Date Received: 02/26/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
Manufacturer: TIFFANI ROGERS
Device Classification Name: Bone Cement, Antibiotic
Regulation Number: MBB
Classification Product Code: 12/28/2006
Date Received: 02/26/2007
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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