The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Redondo-l.
| Device ID | K103297 |
| 510k Number | K103297 |
| Device Name: | REDONDO-L |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862 |
| Contact | Ethel Bernal |
| Correspondent | Ethel Bernal SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-08 |
| Decision Date | 2011-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981035365 | K103297 | 000 |
| 10889981035136 | K103297 | 000 |
| 10889981035129 | K103297 | 000 |
| 10889981035099 | K103297 | 000 |
| 10889981035082 | K103297 | 000 |
| 10889981035075 | K103297 | 000 |
| 10889981035068 | K103297 | 000 |
| 10889981035051 | K103297 | 000 |
| 10889981035044 | K103297 | 000 |
| 10889981035037 | K103297 | 000 |
| 10889981035020 | K103297 | 000 |
| 10889981035013 | K103297 | 000 |
| 10889981035143 | K103297 | 000 |
| 10889981035150 | K103297 | 000 |
| 10889981035181 | K103297 | 000 |
| 10889981035334 | K103297 | 000 |
| 10889981035327 | K103297 | 000 |
| 10889981035310 | K103297 | 000 |
| 10889981035303 | K103297 | 000 |
| 10889981035273 | K103297 | 000 |
| 10889981035266 | K103297 | 000 |
| 10889981035259 | K103297 | 000 |
| 10889981035242 | K103297 | 000 |
| 10889981035211 | K103297 | 000 |
| 10889981035204 | K103297 | 000 |
| 10889981035198 | K103297 | 000 |
| 10889981035006 | K103297 | 000 |