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510(k) K092548

EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS by Extremity Medical, LLC — Product Code KYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2009
Date Received
August 19, 2009
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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  • K212297 — Omni Foot and Ankle Plating System (August 20, 2021)
  • K211261 — Axis Charcot Fixation System (May 28, 2021)
  • K201556 — Intraosseous Fixation System (July 8, 2020)
  • K191525 — KinematX Total Wrist Arthroplasty System (March 4, 2020)
  • K192592 — Axis Plating System (November 21, 2019)
  • K181067 — AlignX Ankle Fusion System (May 23, 2018)
  • K180808 — Omni Foot Plating System (May 22, 2018)

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)
  • 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)
  • K052596 — MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17 (November 15, 2005)