The following data is part of a premarket notification filed by Blue Ortho with the FDA for Exactechgps® System.
| Device ID | K213877 |
| 510k Number | K213877 |
| Device Name: | ExactechGPS® System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Blue Ortho 22, Chemin Du Vieux Chene Meylan, FR 38240 |
| Contact | Matthieu Coic |
| Correspondent | Matthieu Coic Blue Ortho 22, Chemin Du Vieux Chene Meylan, FR 38240 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-13 |
| Decision Date | 2022-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862607195 | K213877 | 000 |
| 10885862607188 | K213877 | 000 |
| 10885862607171 | K213877 | 000 |
| 10885862607164 | K213877 | 000 |
| 10885862625601 | K213877 | 000 |