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510(k) K020153

CONSENSUS ACETABLAR SHELL, TI COATED by Hayes Medical, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2002
Date Received
January 16, 2002
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 Hayes Medical, Inc.

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  • K062383 — UNISYN HA PLASMA MODULAR HIP (December 21, 2006)
  • K060635 — CONSENSUS ACETABULAR SHELL SYSTEM (April 28, 2006)
  • K030151 — CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM (April 10, 2003)
  • K030205 — CONSENSUS UNIPOLAR HEAD, COCR (April 1, 2003)
  • K021466 — CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE (July 24, 2002)
  • K003649 — TRITON HIP SYSTEM (February 23, 2001)
  • K001456 — CONSENSUS KNEE SYSTEM (August 7, 2000)
  • K983004 — CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI (November 25, 1998)
  • K964395 — PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT (January 27, 1997)

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