The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Spinal Fixation System Lateral Offset (system Modification).
| Device ID | K030581 |
| 510k Number | K030581 |
| Device Name: | BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104 |
| Contact | Dean E Ciporkin |
| Correspondent | Dean E Ciporkin BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-24 |
| Decision Date | 2003-06-26 |
| Summary: | summary |