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510(k) K013490

CEMENTED CALCAR HIP SYSTEM by Encore Orthopedics, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2002
Date Received
October 22, 2001
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)
  • 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)
  • K011856 — RADIOGRAPHIC MARKERS (August 22, 2001)

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