The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Malibu Spinal System.
| Device ID | K072605 |
| 510k Number | K072605 |
| Device Name: | MALIBU SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-17 |
| Decision Date | 2007-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981119829 | K072605 | 000 |
| 10889981030018 | K072605 | 000 |
| 10889981030025 | K072605 | 000 |
| 10889981030032 | K072605 | 000 |
| 10889981030049 | K072605 | 000 |
| 10889981030056 | K072605 | 000 |
| 10889981030063 | K072605 | 000 |
| 10889981030070 | K072605 | 000 |
| 10889981030087 | K072605 | 000 |
| 10889981030094 | K072605 | 000 |
| 10889981030100 | K072605 | 000 |
| 10889981030117 | K072605 | 000 |
| 10889981030124 | K072605 | 000 |
| 10889981030131 | K072605 | 000 |
| 10889981030148 | K072605 | 000 |
| 10889981030155 | K072605 | 000 |
| 10889981030162 | K072605 | 000 |
| 10889981003593 | K072605 | 000 |