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 | K162786 |
| 510k Number | K162786 |
| Device Name: | PASS LP Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDICREA INTERNATIONAL S.A 14 Z.A PORTE DU GRAND LYON Neyron, FR 01700 |
| Contact | David Ryan |
| Correspondent | David Ryan MEDICREA INTERNATIONAL S.A 14 Z.A PORTE DU GRAND LYON Neyron, FR 01700 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-03 |
| Decision Date | 2017-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03613720295648 | K162786 | 000 |
| 03613720295631 | K162786 | 000 |
| 03613720274476 | K162786 | 000 |
| 03613720274483 | K162786 | 000 |
| 03613720274490 | K162786 | 000 |
| 03613720274506 | K162786 | 000 |
| 03613720274513 | K162786 | 000 |
| 03613720274520 | K162786 | 000 |
| 03613720274537 | K162786 | 000 |
| 03613720295624 | K162786 | 000 |
| 03613720295747 | K162786 | 000 |
| 03613720295730 | K162786 | 000 |
| 03613720295655 | K162786 | 000 |
| 03613720295662 | K162786 | 000 |
| 03613720295679 | K162786 | 000 |
| 03613720295686 | K162786 | 000 |
| 03613720295693 | K162786 | 000 |
| 03613720295709 | K162786 | 000 |
| 03613720295716 | K162786 | 000 |
| 03613720295723 | K162786 | 000 |
| 03613720274544 | K162786 | 000 |
| 03613720274551 | K162786 | 000 |
| 03613720263524 | K162786 | 000 |
| 03613720263531 | K162786 | 000 |
| 03613720263548 | K162786 | 000 |
| 03613720263562 | K162786 | 000 |
| 03613720263579 | K162786 | 000 |
| 03613720263586 | K162786 | 000 |
| 03613720263685 | K162786 | 000 |
| 03613720263692 | K162786 | 000 |
| 03613720263500 | K162786 | 000 |
| 03613720263494 | K162786 | 000 |
| 03613720263487 | K162786 | 000 |
| 03613720274568 | K162786 | 000 |
| 03613720274575 | K162786 | 000 |
| 03613720274582 | K162786 | 000 |
| 03613720274599 | K162786 | 000 |
| 03613720274605 | K162786 | 000 |
| 03613720274612 | K162786 | 000 |
| 03613720274629 | K162786 | 000 |
| 03613720263470 | K162786 | 000 |
| 03613720263708 | K162786 | 000 |