The following data is part of a premarket notification filed by Soteira, Inc. with the FDA for Shield Kyphoplasty System.
| Device ID | K093477 |
| 510k Number | K093477 |
| Device Name: | SHIELD KYPHOPLASTY SYSTEM |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | SOTEIRA, INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau SOTEIRA, INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-09 |
| Decision Date | 2011-12-08 |
| Summary: | summary |