The following data is part of a premarket notification filed by Imedicom with the FDA for Medinaut Kyphoplasty System.
| Device ID | K133669 |
| 510k Number | K133669 |
| Device Name: | MEDINAUT KYPHOPLASTY SYSTEM |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | IMEDICOM 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung IMEDICOM 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92833 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-29 |
| Decision Date | 2014-04-04 |
| Summary: | summary |