The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Mitek Tight-n Anchor.
| Device ID | K221364 |
| 510k Number | K221364 |
| Device Name: | Mitek TIGHT-N Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Medos International SARL Chemin-Blanc 38, Case Postale Le Locle, CH CH 2400 |
| Contact | Ashley Aromando (Goncalo) |
| Correspondent | Ashley Aromando (Goncalo) DePuy Synthes Mitek Sports Medicine 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 | 2022-05-11 |
| Decision Date | 2022-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705032686 | K221364 | 000 |
| 10886705032655 | K221364 | 000 |
| 10886705032600 | K221364 | 000 |