FDA 510(k), K091423, PROFEMUR HIP SYSTEM MODULAR NECKS

FDA 510(k), K091423, PROFEMUR HIP SYSTEM MODULAR NECKS

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510(K) Number: K091423
Device Name: PROFEMUR HIP SYSTEM MODULAR NECKS
Manufacturer: RYAN ROSS
Device Classification Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation Number: KWA
Classification Product Code: KXA
Date Received: 05/13/2009
Decision Date: 08/25/2009
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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