The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Ascent Posterior Occipital Cervico-thoracic (poct) System.
| Device ID | K080394 |
| 510k Number | K080394 |
| Device Name: | BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 Wayne, NJ 07470 |
| Contact | Whitney G Torning |
| Correspondent | Whitney G Torning BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 Wayne, NJ 07470 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-13 |
| Decision Date | 2008-03-13 |
| Summary: | summary |