The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Navigation Enabled Intruments.
| Device ID | K200791 |
| 510k Number | K200791 |
| Device Name: | Navigation Enabled Intruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Daria Bochenek |
| Correspondent | Nicole Aeschbacher DePuy Synthes Spine Eimattstrasse 3 Oberdorf, CH 4436 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-26 |
| Decision Date | 2020-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034561684 | K200791 | 000 |
| 10705034561318 | K200791 | 000 |
| 10705034561226 | K200791 | 000 |
| 10705034561219 | K200791 | 000 |
| 10705034561660 | K200791 | 000 |
| 10705034561653 | K200791 | 000 |
| 10705034561646 | K200791 | 000 |
| 10705034561677 | K200791 | 000 |
| 10705034561622 | K200791 | 000 |
| 10705034561424 | K200791 | 000 |
| 10705034561370 | K200791 | 000 |
| 10705034561363 | K200791 | 000 |
| 10705034561356 | K200791 | 000 |
| 10705034561301 | K200791 | 000 |
| 10705034561295 | K200791 | 000 |
| 10705034561288 | K200791 | 000 |
| 10705034561264 | K200791 | 000 |
| 10705034561325 | K200791 | 000 |
| 10705034561332 | K200791 | 000 |
| 10705034561349 | K200791 | 000 |
| 10705034561639 | K200791 | 000 |
| 10705034561547 | K200791 | 000 |
| 10705034561530 | K200791 | 000 |
| 10705034561523 | K200791 | 000 |
| 10705034561516 | K200791 | 000 |
| 10705034561509 | K200791 | 000 |
| 10705034561493 | K200791 | 000 |
| 10705034561486 | K200791 | 000 |
| 10705034561479 | K200791 | 000 |
| 10705034561462 | K200791 | 000 |
| 10705034561455 | K200791 | 000 |
| 10705034561448 | K200791 | 000 |
| 10705034561431 | K200791 | 000 |
| 10705034561400 | K200791 | 000 |
| 10705034561394 | K200791 | 000 |
| 10705034561387 | K200791 | 000 |
| 10705034561240 | K200791 | 000 |