The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Ascent Poct System Lateral Offset Adapter.
| Device ID | K040034 |
| 510k Number | K040034 |
| Device Name: | BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104 |
| Contact | Dean Ciporkin |
| Correspondent | Dean Ciporkin BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-08 |
| Decision Date | 2004-02-11 |