ARTELON SPACER CMC-1— 510(k) K040070

Substantially Equivalent

Artimplant AB

FDA 510(k) clearance K040070 for ARTELON SPACER CMC-1, Substantially Equivalent on 2004-09-21. 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: 2004-01-14
Decision date: 2004-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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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
K061954 — ARTELON CMC SPACER ARTHRO2007-06-01
K052830 — SPORTMESH2006-01-19
K052482 — ARTELON SURGICAL SUTURE2005-10-17

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