The following data is part of a premarket notification filed by G21 S.r.l. with the FDA for Winch Kyphoplasty(15 And 20 Mm) 11 Gauge Balloon Catheters.
| Device ID | K152557 |
| 510k Number | K152557 |
| Device Name: | Winch Kyphoplasty(15 And 20 Mm) 11 Gauge Balloon Catheters |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | G21 S.r.l. Via S. Pertini, 8 San Possidonio, IT 41039 |
| Contact | Maurizio Foroni |
| Correspondent | Barry E Sands RQMIS Inc. 29 Water Street, Suite 305 Newburyport, MA 01950 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-08 |
| Decision Date | 2016-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08058964726407 | K152557 | 000 |
| 08058964726339 | K152557 | 000 |