The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Spinal Fixation System 4.5mm Mono-axial Screw.
| Device ID | K013558 |
| 510k Number | K013558 |
| Device Name: | BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104 |
| Contact | Alan Lombardo |
| Correspondent | Alan Lombardo BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-25 |
| Decision Date | 2002-01-23 |
| Summary: | summary |