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 |