The following data is part of a premarket notification filed by Dfine, Inc. with the FDA for Space Cpsxl Bone Cement.
| Device ID | K061531 |
| 510k Number | K061531 |
| Device Name: | SPACE CPSXL BONE CEMENT |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | DFINE, INC. 19450 STEVENS CREEK BLVD. SUITE 100 Cupertino, CA 95014 |
| Contact | Robert D Poser |
| Correspondent | Robert D 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 | 2006-06-02 |
| Decision Date | 2006-08-30 |
| Summary: | summary |