The following data is part of a premarket notification filed by Blackstone with the FDA for Firebird Spinal Fixation System, Firebird Side-loading Body.
| Device ID | K100044 |
| 510k Number | K100044 |
| Device Name: | FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | BLACKSTONE 1211 HAMBURG TURNPIKE, SUITE 300 Wayne, NJ 07470 |
| Contact | Whitney Torning |
| Correspondent | Whitney Torning BLACKSTONE 1211 HAMBURG TURNPIKE, SUITE 300 Wayne, NJ 07470 |
| 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 | 2010-01-08 |
| Decision Date | 2010-02-04 |
| Summary: | summary |