The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Newport Spinal System.
| Device ID | K180176 |
| 510k Number | K180176 |
| Device Name: | SeaSpine NewPort Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 90228 |
| Contact | Gina Flores |
| Correspondent | Gina Flores SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 90228 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-22 |
| Decision Date | 2018-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981277796 | K180176 | 000 |
| 10889981277789 | K180176 | 000 |