The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers.
| Device ID | K041939 |
| 510k Number | K041939 |
| Device Name: | BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | BLACKSTONE MEDICAL, INC. 90 BROOKDALE DR. Springfield, MA 01104 |
| Contact | Dean E Ciporkin |
| Correspondent | Dean E Ciporkin BLACKSTONE MEDICAL, INC. 90 BROOKDALE DR. Springfield, MA 01104 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-19 |
| Decision Date | 2004-08-17 |
| Summary: | summary |