The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Navigated Instrument System.
| Device ID | K172115 |
| 510k Number | K172115 |
| Device Name: | Navigated Instrument System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Orthofix Inc. 3451 Plano Parkway Lewisville, TX 75056 |
| Contact | Jacki Koch |
| Correspondent | Jacki Koch Orthofix Inc. 3451 Plano Parkway Lewisville, TX 75056 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-13 |
| Decision Date | 2018-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18257200121816 | K172115 | 000 |
| 18257200119356 | K172115 | 000 |
| 18257200119363 | K172115 | 000 |
| 18257200119370 | K172115 | 000 |
| 18257200119387 | K172115 | 000 |
| 18257200119394 | K172115 | 000 |
| 18257200119400 | K172115 | 000 |
| 18257200119417 | K172115 | 000 |
| 18257200119486 | K172115 | 000 |
| 18257200119349 | K172115 | 000 |
| 18257200119332 | K172115 | 000 |
| 18257200119257 | K172115 | 000 |
| 18257200119264 | K172115 | 000 |
| 18257200119271 | K172115 | 000 |
| 18257200119288 | K172115 | 000 |
| 18257200119295 | K172115 | 000 |
| 18257200119301 | K172115 | 000 |
| 18257200119318 | K172115 | 000 |
| 18257200119325 | K172115 | 000 |
| 18257200119493 | K172115 | 000 |
| 18257200119509 | K172115 | 000 |
| 18257200119615 | K172115 | 000 |
| 18257200119622 | K172115 | 000 |
| 18257200119639 | K172115 | 000 |
| 18257200119646 | K172115 | 000 |
| 18257200119653 | K172115 | 000 |
| 18257200119813 | K172115 | 000 |
| 18257200119820 | K172115 | 000 |
| 18257200121809 | K172115 | 000 |
| 18257200119608 | K172115 | 000 |
| 18257200119592 | K172115 | 000 |
| 18257200119516 | K172115 | 000 |
| 18257200119523 | K172115 | 000 |
| 18257200119530 | K172115 | 000 |
| 18257200119547 | K172115 | 000 |
| 18257200119554 | K172115 | 000 |
| 18257200119561 | K172115 | 000 |
| 18257200119578 | K172115 | 000 |
| 18257200119585 | K172115 | 000 |
| 18257200119240 | K172115 | 000 |