The following data is part of a premarket notification filed by Dfine, Inc. with the FDA for Space 360 Delivery System.
| Device ID | K070351 |
| 510k Number | K070351 |
| Device Name: | SPACE 360 DELIVERY SYSTEM |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | DFINE, INC. 19450 STEVENS CREEK BLVD. SUITE 100 Cupertino, CA 95014 |
| Contact | Robert Poser |
| Correspondent | Robert Poser DFINE, INC. 19450 STEVENS CREEK BLVD. SUITE 100 Cupertino, CA 95014 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-06 |
| Decision Date | 2007-06-29 |
| Summary: | summary |