The following data is part of a premarket notification filed by Medacta Inernational Sa with the FDA for Myspine S2-alar/alar-iliac Pedicle Screw Placement Guides.
| Device ID | K200792 |
| 510k Number | K200792 |
| Device Name: | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides |
| Classification | Pedicle Screw Placement Guide |
| Applicant | Medacta Inernational SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | PQC |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-26 |
| Decision Date | 2020-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630971255791 | K200792 | 000 |
| 07630971255784 | K200792 | 000 |
| 07630971255777 | K200792 | 000 |
| 07630971255760 | K200792 | 000 |
| 07630040728355 | K200792 | 000 |
| 07630040728348 | K200792 | 000 |