The following data is part of a premarket notification filed by Synthes (usa) Llc with the FDA for Synthes Synflate Vertevral Balloon System.
| Device ID | K130146 |
| 510k Number | K130146 |
| Device Name: | SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | SYNTHES (USA) LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Stacey Bonnell |
| Correspondent | Stacey Bonnell SYNTHES (USA) LLC 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 | 2013-01-22 |
| Decision Date | 2013-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98103804702S0 | K130146 | 000 |
| H98103804701S0 | K130146 | 000 |
| H98103804700S0 | K130146 | 000 |