Home / 510(k) Clearances / K964472

510(k) K964472

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

K964472 is an FDA 510(k) premarket notification submitted by Biologically Oriented Prostheses for the device "RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT". The FDA issued a decision of Substantially Equivalent on February 3, 1997. The device falls under product code KYI (Prosthesis, Wrist, Carpal Trapezium), a Class II device regulated under 21 CFR 888.3770. Biologically Oriented Prostheses has at least 8 other 510(k) clearances on record.

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

Other clearances by Biologically Oriented Prostheses

  • K002325 — WUJIN #3 TIBIAL NAIL (October 30, 2000)
  • K992144 — BIOPRO RIMMED ACETABULAR COMPOMENT (September 22, 1999)
  • K962769 — HORIZON HIP SYSTEM (October 3, 1996)
  • 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)

Other clearances for product code KYI

  • K201072 — Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (December 2, 2020)
  • K180744 — Stablyx CMC Arthroplasty Implant System (April 11, 2018)
  • K111068 — STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 (December 30, 2011)
  • K112278 — ASCENSION NUGRIP CMC IMPLANT (November 4, 2011)
  • K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS (December 15, 2009)
  • K061956 — ARTELON STT SPACER (June 7, 2007)
  • K061954 — ARTELON CMC SPACER ARTHRO (June 1, 2007)
  • K061451 — ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (August 11, 2006)
  • K061089 — MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 1 (June 20, 2006)
  • K060386 — NEXA CARPO METACARPAL IMPLANT (May 10, 2006)

FDA data resources