The following data is part of a premarket notification filed by Medicrea International S.a with the FDA for Pass Oct Spinal System.
| Device ID | K161149 |
| 510k Number | K161149 |
| Device Name: | PASS OCT Spinal System |
| Classification | Posterior Cervical Screw System |
| Applicant | MEDICREA INTERNATIONAL S.A 14 PORTE DU GRAND LYON Neyron, FR 01700 |
| Contact | David Ryan |
| Correspondent | David Ryan MEDICREA INTERNATIONAL S.A 14 PORTE DU GRAND LYON Neyron, FR 01700 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-25 |
| Decision Date | 2016-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03613720266808 | K161149 | 000 |
| 03613720266792 | K161149 | 000 |
| 03613720266785 | K161149 | 000 |
| 03613720266778 | K161149 | 000 |
| 03613720265016 | K161149 | 000 |
| 03613720265009 | K161149 | 000 |
| 03613720237068 | K161149 | 000 |