The following data is part of a premarket notification filed by Artimplant Ab with the FDA for Artelon Cmc Spacer Arthro.
Device ID | K061954 |
510k Number | K061954 |
Device Name: | ARTELON CMC SPACER ARTHRO |
Classification | Prosthesis, Wrist, Carpal Trapezium |
Applicant | ARTIMPLANT AB 719 A STREET NE Washington, DC 20002 |
Contact | Russell Pagano |
Correspondent | Russell Pagano ARTIMPLANT AB 719 A STREET NE Washington, DC 20002 |
Product Code | KYI |
CFR Regulation Number | 888.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-11 |
Decision Date | 2007-06-01 |
Summary: | summary |