The following data is part of a premarket notification filed by Medicrea International with the FDA for Pass Lp Spinal System.
| Device ID | K132574 |
| 510k Number | K132574 |
| Device Name: | PASS LP SPINAL SYSTEM |
| Classification | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| 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 | OSH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-16 |
| Decision Date | 2013-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03613720184034 | K132574 | 000 |
| 03613720184027 | K132574 | 000 |
| 03613720180562 | K132574 | 000 |
| 03613720180555 | K132574 | 000 |