The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Navigated Infinity™ Instruments.
| Device ID | K173338 |
| 510k Number | K173338 |
| Device Name: | Navigated INFINITY™ Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Tejas Patel |
| Correspondent | Tejas Patel Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-23 |
| Decision Date | 2018-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169862494 | K173338 | 000 |
| 00643169862470 | K173338 | 000 |
| 00643169839663 | K173338 | 000 |
| 00643169778344 | K173338 | 000 |
| 00643169725423 | K173338 | 000 |
| 00643169725461 | K173338 | 000 |
| 00643169725454 | K173338 | 000 |
| 00643169725447 | K173338 | 000 |
| 00643169725430 | K173338 | 000 |