The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Healix Advance Anchor With Permatape Suture.
Device ID | K170639 |
510k Number | K170639 |
Device Name: | HEALIX ADVANCE Anchor With PERMATAPE Suture |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | Medos International SARL Chemin-Blanc 38, Case Postale Le Locle, CH Ch 2400 |
Contact | Julie Vafides |
Correspondent | Julie Vafides DePuy Mitek, Inc., A 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 | 2017-03-02 |
Decision Date | 2017-05-18 |
Summary: | summary |