The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Healix Advance Knotless Br Anchor.
Device ID | K130917 |
510k Number | K130917 |
Device Name: | HEALIX ADVANCE KNOTLESS BR ANCHOR |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Yayoi Fujimaki |
Correspondent | Yayoi Fujimaki DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-03 |
Decision Date | 2013-05-24 |
Summary: | summary |