The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Skipjack System.
| Device ID | K193418 |
| 510k Number | K193418 |
| Device Name: | SeaSpine Skipjack System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Aly Alvarez |
| Correspondent | Aly Alvarez SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-09 |
| Decision Date | 2020-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981207137 | K193418 | 000 |
| 10889981184902 | K193418 | 000 |
| 10889981184919 | K193418 | 000 |
| 10889981206468 | K193418 | 000 |
| 10889981206475 | K193418 | 000 |
| 10889981206482 | K193418 | 000 |
| 10889981206499 | K193418 | 000 |
| 10889981206505 | K193418 | 000 |
| 10889981206529 | K193418 | 000 |
| 10889981206543 | K193418 | 000 |
| 10889981206550 | K193418 | 000 |
| 10889981206567 | K193418 | 000 |
| 10889981206581 | K193418 | 000 |
| 10889981206604 | K193418 | 000 |
| 10889981206727 | K193418 | 000 |
| 10889981206741 | K193418 | 000 |
| 10889981206758 | K193418 | 000 |
| 10889981206772 | K193418 | 000 |
| 10889981184896 | K193418 | 000 |