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510(k) K061954

ARTELON CMC SPACER ARTHRO by Artimplant AB — Product Code KYI

K061954 is an FDA 510(k) premarket notification submitted by Artimplant AB for the device "ARTELON CMC SPACER ARTHRO". The FDA issued a decision of Substantially Equivalent on June 1, 2007. The device falls under product code KYI (Prosthesis, Wrist, Carpal Trapezium), a Class II device regulated under 21 CFR 888.3770. Artimplant AB has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2007
Date Received
July 11, 2006
Clearance Type
Special
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 Artimplant AB

  • K071887 — SPORTMESH OR ARTELON TISSUE REINFORCEMENT (September 18, 2007)
  • K061956 — ARTELON STT SPACER (June 7, 2007)
  • K052830 — SPORTMESH (January 19, 2006)
  • K052482 — ARTELON SURGICAL SUTURE (October 17, 2005)
  • K040070 — ARTELON SPACER CMC-1 (September 21, 2004)
  • K032160 — ARTELON SURGICAL SUTURE (November 17, 2003)

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)
  • 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)

FDA data resources