The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Firebird Spinal Fixation System.
| Device ID | K093926 |
| 510k Number | K093926 |
| Device Name: | FIREBIRD SPINAL FIXATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 Wayne, NJ 07470 |
| Contact | Russell Johnson |
| Correspondent | Russell Johnson BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 Wayne, NJ 07470 |
| 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 | 2009-12-22 |
| Decision Date | 2010-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18257200014477 | K093926 | 000 |
| 18257200014453 | K093926 | 000 |