ARTELON CMC SPACER ARTHRO— 510(k) K061954

Substantially Equivalent

Artimplant AB

FDA 510(k) clearance K061954 for ARTELON CMC SPACER ARTHRO, Substantially Equivalent on 2007-06-01. Applicant: Artimplant AB. Device class: 2.

Clearance details

Applicant: Artimplant AB
Product code: Code KYI
Device class: Class 2
Regulation: 21 CFR 888.3770
Advisory panel: Orthopedic
Date received: 2006-07-11
Decision date: 2007-06-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYI

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K112278 — ASCENSION NUGRIP CMC IMPLANT2011-11-04
K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS2009-12-15

More clearances from Artimplant AB

K071887 — SPORTMESH OR ARTELON TISSUE REINFORCEMENT2007-09-18
K061956 — ARTELON STT SPACER2007-06-07
K052830 — SPORTMESH2006-01-19
K052482 — ARTELON SURGICAL SUTURE2005-10-17
K040070 — ARTELON SPACER CMC-12004-09-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.