The following data is part of a premarket notification filed by Medicrea International S.a. with the FDA for Pass Lp Spinal System.
| Device ID | K142798 |
| 510k Number | K142798 |
| Device Name: | PASS LP Spinal System |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | MEDICREA INTERNATIONAL S.A. 14 PORTE DU GRAND LYON Neyron, FR 01700 |
| Contact | Audrey Vion |
| Correspondent | Audrey Vion MEDICREA INTERNATIONAL S.A. 14 PORTE DU GRAND LYON Neyron, FR 01700 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-29 |
| Decision Date | 2015-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03613720249467 | K142798 | 000 |
| 03613720184263 | K142798 | 000 |
| 03613720184409 | K142798 | 000 |
| 03613720184423 | K142798 | 000 |
| 03613720184447 | K142798 | 000 |
| 03613720184461 | K142798 | 000 |
| 03613720249368 | K142798 | 000 |
| 03613720249375 | K142798 | 000 |
| 03613720249382 | K142798 | 000 |
| 03613720249399 | K142798 | 000 |
| 03613720249405 | K142798 | 000 |
| 03613720249412 | K142798 | 000 |
| 03613720249429 | K142798 | 000 |
| 03613720249436 | K142798 | 000 |
| 03613720249443 | K142798 | 000 |
| 03613720249450 | K142798 | 000 |
| 03613720184249 | K142798 | 000 |