The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Pillar Sa Partial Vertebral Body Replacement Device.
| Device ID | K081849 |
| 510k Number | K081849 |
| Device Name: | BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| 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 | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-30 |
| Decision Date | 2008-08-28 |
| Summary: | summary |