The following data is part of a premarket notification filed by G-21 S.r.l. with the FDA for Modified Winch Kyphoplasty (15 And 20 Mm) 11 Gauge Balloon Catheters.
| Device ID | K172214 |
| 510k Number | K172214 |
| Device Name: | Modified Winch Kyphoplasty (15 And 20 Mm) 11 Gauge Balloon Catheters |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | G-21 S.r.l. Via S. Pertini, 8 San Possidonio, IT 41039 |
| Contact | Maurizio Foroni |
| Correspondent | Paul Speidel Rqmis, Inc. 110 Haverhill Road Suite 526 Amesbury, MA 01913 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-24 |
| Decision Date | 2017-08-23 |
| Summary: | summary |