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510(k) K000521

KEYSTONE HIP by Encore Orthopedics, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2000
Date Received
February 16, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Encore Orthopedics, Inc.

  • K032905 — 3DKNEE POROUS COATED FEMORAL COMPONENT (July 6, 2004)
  • K020114 — 3D KNEE (July 12, 2002)
  • K020741 — UNICONDYLAR KNEE (June 4, 2002)
  • K020236 — MODIFICATION TO PASS SPINAL SYSTEM (February 14, 2002)
  • K020170 — KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP (February 11, 2002)
  • K013490 — CEMENTED CALCAR HIP SYSTEM (January 17, 2002)
  • K013442 — PASS SPINAL SYSTEM (January 15, 2002)
  • K003324 — PLASMA SPRAYED SHOULDER (December 6, 2001)
  • K013431 — PASS SPINAL SYSTEM (November 15, 2001)
  • K013191 — PASS SPINAL SYSTEM (October 24, 2001)

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