The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Cambria System.
| Device ID | K171046 |
| 510k Number | K171046 |
| Device Name: | SeaSpine Cambria System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Gina Flores |
| Correspondent | Gina Flores SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-07 |
| Decision Date | 2017-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981143756 | K171046 | 000 |
| 10889981143626 | K171046 | 000 |
| 10889981143619 | K171046 | 000 |
| 10889981143602 | K171046 | 000 |
| 10889981143596 | K171046 | 000 |
| 10889981143589 | K171046 | 000 |
| 10889981143572 | K171046 | 000 |
| 10889981143565 | K171046 | 000 |
| 10889981143558 | K171046 | 000 |
| 10889981143541 | K171046 | 000 |
| 10889981143534 | K171046 | 000 |
| 10889981143633 | K171046 | 000 |
| 10889981143640 | K171046 | 000 |
| 10889981143749 | K171046 | 000 |
| 10889981143732 | K171046 | 000 |
| 10889981143725 | K171046 | 000 |
| 10889981143718 | K171046 | 000 |
| 10889981143701 | K171046 | 000 |
| 10889981143695 | K171046 | 000 |
| 10889981143688 | K171046 | 000 |
| 10889981143671 | K171046 | 000 |
| 10889981143664 | K171046 | 000 |
| 10889981143657 | K171046 | 000 |
| 10889981143527 | K171046 | 000 |