The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Rigidloop Titanium Button , Rigidloop Cortical Fixation System Xl Implant.
| Device ID | K190774 |
| 510k Number | K190774 |
| Device Name: | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Leeann Walosin |
| Correspondent | Leeann Walosin DePuy Mitek, Inc. 325 Paramount Drive Raynham, MA 02767 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-26 |
| Decision Date | 2019-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705030781 | K190774 | 000 |