The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Modification To Blackstone Spinal Fixation System.
| Device ID | K023498 |
| 510k Number | K023498 |
| Device Name: | MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-18 |
| Decision Date | 2002-11-13 |
| Summary: | summary |