The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Symphony Navigation Ready Instruments, Universal Navigation Adaptor Set.
| Device ID | K191943 |
| 510k Number | K191943 |
| Device Name: | SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medos International, SARL Chemin-Blanc 38 Le Loche, CH 2400 |
| Contact | Daria Bochenek |
| Correspondent | Daria Bochenek 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 | 2019-07-22 |
| Decision Date | 2019-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034532776 | K191943 | 000 |
| 10705034530918 | K191943 | 000 |
| 10705034530901 | K191943 | 000 |
| 10705034530895 | K191943 | 000 |
| 10705034530888 | K191943 | 000 |
| 10705034530871 | K191943 | 000 |
| 10705034530864 | K191943 | 000 |
| 10705034530857 | K191943 | 000 |
| 10705034530710 | K191943 | 000 |
| 10705034530451 | K191943 | 000 |
| 10705034530420 | K191943 | 000 |
| 10705034530321 | K191943 | 000 |
| 10705034530406 | K191943 | 000 |
| 10705034530925 | K191943 | 000 |
| 10705034530932 | K191943 | 000 |
| 10705034532578 | K191943 | 000 |
| 10705034532554 | K191943 | 000 |
| 10705034531892 | K191943 | 000 |
| 10705034531885 | K191943 | 000 |
| 10705034531830 | K191943 | 000 |
| 10705034531823 | K191943 | 000 |
| 10705034531816 | K191943 | 000 |
| 10705034531021 | K191943 | 000 |
| 10705034530994 | K191943 | 000 |
| 10705034530987 | K191943 | 000 |
| 10705034530956 | K191943 | 000 |
| 10705034530949 | K191943 | 000 |
| 10705034558158 | K191943 | 000 |