The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Healix Advance Anchor With Dyna+tape Sutures.
Device ID | K191483 |
510k Number | K191483 |
Device Name: | HEALIX ADVANCE Anchor With DYNA+TAPE Sutures |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | Medos International SARL Chemin-Blanc 38, Case Postale Le Locle, CH Ch 2400 |
Contact | Ashley Goncalo |
Correspondent | Ashley Goncalo DePuy Synthes Mitek, 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 | 2019-06-04 |
Decision Date | 2019-06-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10886705030941 | K191483 | 000 |
10886705030842 | K191483 | 000 |
10886705030859 | K191483 | 000 |
10886705030866 | K191483 | 000 |
10886705030873 | K191483 | 000 |
10886705030880 | K191483 | 000 |
10886705030897 | K191483 | 000 |
10886705030903 | K191483 | 000 |
10886705030910 | K191483 | 000 |
10886705030927 | K191483 | 000 |
10886705030934 | K191483 | 000 |
10886705030835 | K191483 | 000 |