The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Medical, Inc., Pillar Spacer System.
| Device ID | K081177 |
| 510k Number | K081177 |
| Device Name: | BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-25 |
| Decision Date | 2008-07-23 |
| Summary: | summary |