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510(k) K021466

CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE by Hayes Medical, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2002
Date Received
May 7, 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.

  • K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT (January 31, 2007)
  • 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)
  • K020153 — CONSENSUS ACETABLAR SHELL, TI COATED (April 15, 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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