The following data is part of a premarket notification filed by Dfine, Inc. with the FDA for Modification To Space Cpsxl Bone Cement.
| Device ID | K072496 |
| 510k Number | K072496 |
| Device Name: | MODIFICATION TO SPACE CPSXL BONE CEMENT |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | DFINE, INC. 3047 ORCHARD PKWY. San Jose, CA 95134 |
| Contact | Robert Poser |
| Correspondent | Robert Poser DFINE, INC. 3047 ORCHARD PKWY. San Jose, CA 95134 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-05 |
| Decision Date | 2007-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450379858 | K072496 | 000 |
| 10884450315894 | K072496 | 000 |
| 10884450314484 | K072496 | 000 |
| 10884450314316 | K072496 | 000 |
| 10884450296506 | K072496 | 000 |
| 10884450296469 | K072496 | 000 |
| 10884450296315 | K072496 | 000 |
| 10884450296308 | K072496 | 000 |
| 10884450296278 | K072496 | 000 |
| 10884450379902 | K072496 | 000 |
| 00884450314074 | K072496 | 000 |
| 10884450413996 | K072496 | 000 |
| 00884450314081 | K072496 | 000 |
| 10884450441456 | K072496 | 000 |
| 10884450315900 | K072496 | 000 |
| 10884450315917 | K072496 | 000 |
| 10884450315924 | K072496 | 000 |
| 10884450379841 | K072496 | 000 |
| 10884450379834 | K072496 | 000 |
| 10884450379827 | K072496 | 000 |
| 10884450325763 | K072496 | 000 |
| 10884450325701 | K072496 | 000 |
| 10884450325664 | K072496 | 000 |
| 10884450325640 | K072496 | 000 |
| 10884450325619 | K072496 | 000 |
| 10884450325602 | K072496 | 000 |
| 10884450317669 | K072496 | 000 |
| 10884450317652 | K072496 | 000 |
| 10884450317645 | K072496 | 000 |
| 10884450317638 | K072496 | 000 |
| 10884450503338 | K072496 | 000 |