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510(k) K962769

HORIZON HIP SYSTEM by Biologically Oriented Prostheses — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1996
Date Received
July 16, 1996
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

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  • K955916 — TOWNLEY TOTAL ELBOW SYSTEM (August 8, 1996)
  • K954768 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (January 18, 1996)
  • K952731 — TOWNLEY ALL POLY ACETABULAR CUP (December 28, 1995)
  • K953045 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (September 27, 1995)
  • K951356 — VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED (June 19, 1995)

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