The following data is part of a premarket notification filed by Depuy Mitek Inc., Johnson And Johnson Company with the FDA for Healix Advance Br Anchor.
Device ID | K120078 |
510k Number | K120078 |
Device Name: | HEALIX ADVANCE BR ANCHOR |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
Contact | Yayoi Fujimaki |
Correspondent | Yayoi Fujimaki DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY 325 Paramount Drive 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 | 2012-01-10 |
Decision Date | 2012-02-29 |
Summary: | summary |