The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Universal Navigation Instruments.
| Device ID | K140927 |
| 510k Number | K140927 |
| Device Name: | UNIVERSAL NAVIGATION INSTRUMENTS |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Contact | Kirsten Lehmuller |
| Correspondent | Kirsten Lehmuller MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-11 |
| Decision Date | 2014-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034515809 | K140927 | 000 |
| 10705034472249 | K140927 | 000 |
| 10705034472232 | K140927 | 000 |
| 10705034472225 | K140927 | 000 |