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 | K162567 |
| 510k Number | K162567 |
| Device Name: | ExactechGPS Total Shoulder Application, Equinoxe Planning Software |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Blue Ortho 5 Avenue Du Grand Sablon La Tronche, FR 38700 |
| Contact | Anthony Boyer |
| Correspondent | Anthony Boyer Blue Ortho 5 Avenue Du Grand Sablon La Tronche, FR 38700 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-14 |
| Decision Date | 2017-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862591166 | K162567 | 000 |
| 10885862314338 | K162567 | 000 |
| 10885862314321 | K162567 | 000 |
| 10885862308238 | K162567 | 000 |
| 10885862308146 | K162567 | 000 |
| 10885862308184 | K162567 | 000 |
| 10885862308177 | K162567 | 000 |
| 10885862539229 | K162567 | 000 |
| 10885862539212 | K162567 | 000 |
| 10885862539205 | K162567 | 000 |
| 10885862539199 | K162567 | 000 |
| 10885862539182 | K162567 | 000 |
| 10885862539175 | K162567 | 000 |
| 10885862629425 | K162567 | 000 |
| 10885862319272 | K162567 | 000 |
| 10885862527769 | K162567 | 000 |
| 10885862527776 | K162567 | 000 |
| 10885862586810 | K162567 | 000 |
| 10885862583215 | K162567 | 000 |
| 10885862583208 | K162567 | 000 |
| 10885862583192 | K162567 | 000 |
| 10885862583185 | K162567 | 000 |
| 10885862583178 | K162567 | 000 |
| 10885862578242 | K162567 | 000 |
| 10885862578228 | K162567 | 000 |
| 10885862578211 | K162567 | 000 |
| 10885862578204 | K162567 | 000 |
| 10885862578198 | K162567 | 000 |
| 10885862542038 | K162567 | 000 |
| 10885862535641 | K162567 | 000 |
| 10885862654793 | K162567 | 000 |