The following data is part of a premarket notification filed by Astura Medical with the FDA for Olympic Navigated Instruments.
| Device ID | K172166 |
| 510k Number | K172166 |
| Device Name: | OLYMPIC Navigated Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Astura Medical 3186 Lionshead Avenue Suite 100 Carlsbad, CA 92010 |
| Contact | Troy Taylor |
| Correspondent | Parker Kelch Astura Medical 3186 Lionshead Avenue Suite 100 Carlsbad, CA 92010 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-18 |
| Decision Date | 2018-04-27 |
| Summary: | summary |