The following data is part of a premarket notification filed by Blue Ortho with the FDA for Exactechgps System.
| Device ID | K193618 |
| 510k Number | K193618 |
| Device Name: | ExactechGPS System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Blue Ortho 6 Allee De Bethleem Gieres, FR 38610 |
| Contact | Matthieu Coic |
| Correspondent | Matthieu Coic Blue Ortho 6 Allee De Bethleem Gieres, FR 38610 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-26 |
| Decision Date | 2020-09-02 |