The following data is part of a premarket notification filed by Synthes with the FDA for Vbb System.
| Device ID | K110604 |
| 510k Number | K110604 |
| Device Name: | VBB SYSTEM |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | SYNTHES 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Jason Lipman |
| Correspondent | Jason Lipman SYNTHES 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-03 |
| Decision Date | 2011-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98103804413S0 | K110604 | 000 |
| H98103804502S0 | K110604 | 000 |
| H98103804501S0 | K110604 | 000 |
| H98103804500S0 | K110604 | 000 |