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510(k) K964472

RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT by Biologically Oriented Prostheses — Product Code KYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1997
Date Received
November 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Carpal Trapezium
Device Class
Class II
Regulation Number
888.3770
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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