The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Medical Inc. Anterior Cervical Plate System.
| Device ID | K974885 |
| 510k Number | K974885 |
| Device Name: | BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104 |
| Contact | Matthew Lyon |
| Correspondent | Matthew Lyon 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 | 1997-12-30 |
| Decision Date | 1998-06-17 |
| Summary: | summary |