The following data is part of a premarket notification filed by Bk Meditech Co., Ltd. with the FDA for Mega Spine System.
| Device ID | K072436 |
| 510k Number | K072436 |
| Device Name: | MEGA SPINE SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | BK MEDITECH CO., LTD. 25041 FARRIER CIRCLE Laguna Hills, CA 92653 |
| Contact | Henry Yang |
| Correspondent | Henry Yang BK MEDITECH CO., LTD. 25041 FARRIER CIRCLE Laguna Hills, CA 92653 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-30 |
| Decision Date | 2007-11-01 |
| Summary: | summary |