The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Spinous Process System.
| Device ID | K173334 |
| 510k Number | K173334 |
| Device Name: | SeaSpine Spinous Process System |
| Classification | Spinous Process Plate |
| 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 | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-23 |
| Decision Date | 2018-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981096311 | K173334 | 000 |
| 10889981146436 | K173334 | 000 |
| 10889981146443 | K173334 | 000 |
| 10889981146450 | K173334 | 000 |
| 10889981146467 | K173334 | 000 |
| 10889981146474 | K173334 | 000 |
| 10889981146481 | K173334 | 000 |
| 10889981096298 | K173334 | 000 |
| 10889981096304 | K173334 | 000 |
| 10889981146412 | K173334 | 000 |