The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Myspine Pedicle Screw Placement Guides – Mc And Drill Pilot Instruments.
| Device ID | K173472 |
| 510k Number | K173472 |
| Device Name: | MySpine Pedicle Screw Placement Guides – MC And Drill Pilot Instruments |
| Classification | Pedicle Screw Placement Guide |
| 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 | PQC |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-09 |
| Decision Date | 2018-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630971257870 | K173472 | 000 |
| 07630971262584 | K173472 | 000 |
| 07630971262645 | K173472 | 000 |
| 07630971262638 | K173472 | 000 |
| 07630971262621 | K173472 | 000 |
| 07630971262614 | K173472 | 000 |
| 07630971262607 | K173472 | 000 |
| 07630971262591 | K173472 | 000 |
| 07630971262652 | K173472 | 000 |
| 07630971262737 | K173472 | 000 |
| 07630971262720 | K173472 | 000 |
| 07630971257887 | K173472 | 000 |
| 07630971257863 | K173472 | 000 |
| 07630971257856 | K173472 | 000 |
| 07630971257849 | K173472 | 000 |
| 07630971257825 | K173472 | 000 |
| 07630971257818 | K173472 | 000 |
| 07630040717236 | K173472 | 000 |
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| 07630971257832 | K173472 | 000 |
| 07630040717571 | K173472 | 000 |
| 07630040717557 | K173472 | 000 |
| 07630040717533 | K173472 | 000 |
| 07630040717519 | K173472 | 000 |
| 07630040717496 | K173472 | 000 |
| 07630040717472 | K173472 | 000 |
| 07630040717458 | K173472 | 000 |
| 07630040717434 | K173472 | 000 |
| 07630040717410 | K173472 | 000 |
| 07630040717397 | K173472 | 000 |
| 07630040717373 | K173472 | 000 |
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| 07630040717335 | K173472 | 000 |
| 07630040717311 | K173472 | 000 |
| 07630040717298 | K173472 | 000 |
| 07630971257740 | K173472 | 000 |