The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Symphony Navigation Ready Instruments And Universal Navigation Adaptor Set.
| Device ID | K201661 |
| 510k Number | K201661 |
| Device Name: | Symphony Navigation Ready Instruments And Universal Navigation Adaptor Set |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Nicole Aeschbacher |
| 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 | 2020-06-18 |
| Decision Date | 2020-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034536224 | K201661 | 000 |
| 10705034536217 | K201661 | 000 |
| 10705034536200 | K201661 | 000 |
| 10705034536194 | K201661 | 000 |
| 10705034536187 | K201661 | 000 |
| 10705034536156 | K201661 | 000 |