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510(k) K964395

PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT by Hayes Medical, Inc. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1997
Date Received
November 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
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)
  • K021466 — CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE (July 24, 2002)
  • 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)

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