The following data is part of a premarket notification filed by Depuy Mitek Inc., A Johnson And Johnson Company with the FDA for Healix Advance Knotless Peek Anchor (6.5mm).
Device ID | K131683 |
510k Number | K131683 |
Device Name: | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
Contact | Kristine Christo |
Correspondent | Kristine Christo DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-10 |
Decision Date | 2013-06-27 |
Summary: | summary |