The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Seaspine Spacer System.
| Device ID | K102026 |
| 510k Number | K102026 |
| Device Name: | SEASPINE SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SEASPINE, INC. 2301 LA MIRADA DR Vista, CA 92081 |
| Contact | Dan Miller |
| Correspondent | Dan Miller SEASPINE, INC. 2301 LA MIRADA DR Vista, CA 92081 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-19 |
| Decision Date | 2011-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981034856 | K102026 | 000 |
| 10889981034641 | K102026 | 000 |
| 10889981034634 | K102026 | 000 |
| 10889981034627 | K102026 | 000 |
| 10889981034610 | K102026 | 000 |
| 10889981034603 | K102026 | 000 |
| 10889981034597 | K102026 | 000 |
| 10889981034580 | K102026 | 000 |
| 10889981034573 | K102026 | 000 |
| 10889981034566 | K102026 | 000 |
| 10889981034559 | K102026 | 000 |
| 10889981034542 | K102026 | 000 |
| 10889981034535 | K102026 | 000 |
| 10889981034658 | K102026 | 000 |
| 10889981034665 | K102026 | 000 |
| 10889981034672 | K102026 | 000 |
| 10889981034849 | K102026 | 000 |
| 10889981034832 | K102026 | 000 |
| 10889981034825 | K102026 | 000 |
| 10889981034818 | K102026 | 000 |
| 10889981034801 | K102026 | 000 |
| 10889981034795 | K102026 | 000 |
| 10889981034788 | K102026 | 000 |
| 10889981034771 | K102026 | 000 |
| 10889981034719 | K102026 | 000 |
| 10889981034702 | K102026 | 000 |
| 10889981034696 | K102026 | 000 |
| 10889981034689 | K102026 | 000 |
| 10889981034528 | K102026 | 000 |