The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Seaspine Monopolar Probe Sysyem.
| Device ID | K111671 |
| 510k Number | K111671 |
| Device Name: | SEASPINE MONOPOLAR PROBE SYSYEM |
| Classification | Stimulator, Nerve |
| Applicant | SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862 |
| Contact | Dan Miller |
| Correspondent | Dan Miller SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-15 |
| Decision Date | 2011-12-28 |
| Summary: | summary |