The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Healix Advance Anchor With Dynacord Suture.
Device ID | K183506 |
510k Number | K183506 |
Device Name: | HEALIX ADVANCE Anchor With DYNACORD Suture |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | Medos International SARL Chemin-Blanc 38, Case Postale Le Locle, CH Ch 2400 |
Contact | Tatyana Korsunsky |
Correspondent | Tatyana Korsunsky DePuy Mitek, 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 | 2018-12-18 |
Decision Date | 2019-02-14 |
Summary: | summary |