The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Modification To: Bioknotless Br Anchor / Lupine Br Anchor.
Device ID | K070925 |
510k Number | K070925 |
Device Name: | MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Kristine Christo |
Correspondent | Kristine Christo DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | MAI |
Subsequent Product Code | GAM |
Subsequent Product Code | GAS |
Subsequent Product Code | GAT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-04-03 |
Decision Date | 2007-05-02 |
Summary: | summary |