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: KXA
Date Received: 12/28/2006
Decision Date: 02/26/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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