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FDA 510(k), K060358, PROFEMUR TL HIP STEM
FDA 510(k), K060358, PROFEMUR TL HIP STEM
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510(K) Number: K060358
Device Name: PROFEMUR TL HIP STEM
Manufacturer: MATT PAUL
Device Classification Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation Number: KWA
Classification Product Code: KXA
Date Received: 02/13/2006
Decision Date: 05/10/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: PROFEMUR TL HIP STEM
Manufacturer: MATT PAUL
Device Classification Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation Number: KWA
Classification Product Code: KXA
Date Received: 02/13/2006
Decision Date: 05/10/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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