The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Navigated Instrument System.
| Device ID | K162921 |
| 510k Number | K162921 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-18 |
| Decision Date | 2017-03-13 |
| Summary: | summary |