FDA 510(k), K070095, TRIATHLON TS KNEE SYSTEM
FDA 510(k), K070095, TRIATHLON TS KNEE SYSTEM
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510(K) Number: K070095
Device Name: TRIATHLON TS KNEE SYSTEM
Manufacturer: TIFFANI ROGERS
Device Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation Number: JWH
Classification Product Code: 01/10/2007
Date Received: 06/01/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: TRIATHLON TS KNEE SYSTEM
Manufacturer: TIFFANI ROGERS
Device Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation Number: JWH
Classification Product Code: 01/10/2007
Date Received: 06/01/2007
Decision Date: Substantially Equivalent (SESE)
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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