The following data is part of a premarket notification filed by Medacta International Sa with the FDA for M.u.s.t. Combined Set Screws.
| Device ID | K171758 |
| 510k Number | K171758 |
| Device Name: | M.U.S.T. Combined Set Screws |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Roshana Ahmed, M.a., Rac Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, KY 40504 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-14 |
| Decision Date | 2017-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040717069 | K171758 | 000 |
| 07630040717052 | K171758 | 000 |
| 07630040716086 | K171758 | 000 |
| 07630040716079 | K171758 | 000 |
| 07630040716062 | K171758 | 000 |