The following data is part of a premarket notification filed by Medacta International Sa with the FDA for M-ars Acl: Anatomic Ribbon Surgery System.
| Device ID | K171640 |
| 510k Number | K171640 |
| Device Name: | M-ARS ACL: Anatomic Ribbon Surgery System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Elizabeth Rose Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, KY 40504 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2017-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040715751 | K171640 | 000 |
| 07630040715744 | K171640 | 000 |