The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System.
| Device ID | K153428 |
| 510k Number | K153428 |
| Device Name: | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Contact | Jacki Geren |
| Correspondent | Jacki Geren ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-25 |
| Decision Date | 2016-01-29 |