The following data is part of a premarket notification filed by Imedicom Co., Ltd. with the FDA for Medinaut Kyphoplasty System.
| Device ID | K153296 |
| 510k Number | K153296 |
| Device Name: | MEDINAUT Kyphoplasty System |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | IMEDICOM Co., Ltd. #612, 172, LS-ro Gunpo-si, KR 435-824 |
| Contact | Bonggu Ha |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-13 |
| Decision Date | 2016-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809317170107 | K153296 | 000 |
| 08800038059344 | K153296 | 000 |
| 08800038059337 | K153296 | 000 |
| 08800038059320 | K153296 | 000 |
| 08800038059313 | K153296 | 000 |
| 08800038059306 | K153296 | 000 |
| 08800038059290 | K153296 | 000 |
| 08800038059283 | K153296 | 000 |
| 08800038059276 | K153296 | 000 |
| 08800038059269 | K153296 | 000 |
| 08800038056305 | K153296 | 000 |
| 08800038056312 | K153296 | 000 |
| 08800038056329 | K153296 | 000 |
| 08809317170077 | K153296 | 000 |
| 08800038055643 | K153296 | 000 |
| 08800038056183 | K153296 | 000 |
| 08800038056176 | K153296 | 000 |
| 08800038056169 | K153296 | 000 |
| 08800038056152 | K153296 | 000 |
| 08800038056145 | K153296 | 000 |
| 08800038056343 | K153296 | 000 |
| 08800038056336 | K153296 | 000 |
| 08800038059252 | K153296 | 000 |