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 |