The following data is part of a premarket notification filed by Medicrea International with the FDA for Pass Lp Spinal System.
| Device ID | K150049 |
| 510k Number | K150049 |
| Device Name: | PASS LP Spinal System |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | MEDICREA INTERNATIONAL 14 PORTE DU GRAND LYON Neyron, FR 01700 |
| Contact | Audrey Vion |
| Correspondent | Audrey Vion MEDICREA INTERNATIONAL 14 PORTE DU GRAND LYON Neyron, FR 01700 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-12 |
| Decision Date | 2015-02-10 |
| Summary: | summary |