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 |