The following data is part of a premarket notification filed by Blue Ortho with the FDA for Exactechgps Total Shoulder Application, Equinoxe Planning Software.
| Device ID | K213546 |
| 510k Number | K213546 |
| Device Name: | ExactechGPS Total Shoulder Application, Equinoxe Planning Software |
| 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 | 2021-11-08 |
| Decision Date | 2022-01-06 |