FDA 510(k), K001277, TRIFLANGE ACETABULAR CUP SYSTEM

FDA 510(k), K001277, TRIFLANGE ACETABULAR CUP SYSTEM

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510(K) Number: K001277
Device Name: TRIFLANGE ACETABULAR CUP SYSTEM
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation Number: 888.3358
Classification Product Code: LPH
Date Received: 04/21/2000
Decision Date: 06/23/2000
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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