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FDA 510(k), K121221, PROFEMUR Z REVISION HIP STEM
FDA 510(k), K121221, PROFEMUR Z REVISION HIP STEM
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510(K) Number: K121221
Device Name: PROFEMUR Z REVISION HIP STEM
Manufacturer: YUAN LI
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation Number: LZO
Classification Product Code: 04/23/2012
Date Received: 08/09/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: PROFEMUR Z REVISION HIP STEM
Manufacturer: YUAN LI
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation Number: LZO
Classification Product Code: 04/23/2012
Date Received: 08/09/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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