The following data is part of a premarket notification filed by Orthofix with the FDA for Firebird Spinal Fixation System.
| Device ID | K130176 |
| 510k Number | K130176 |
| Device Name: | FIREBIRD SPINAL FIXATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ORTHOFIX 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Contact | Jacki Geren |
| Correspondent | Jacki Geren ORTHOFIX 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-25 |
| Decision Date | 2013-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18257200049325 | K130176 | 000 |
| 18257200049318 | K130176 | 000 |