The following data is part of a premarket notification filed by Lsk Biopartners, Inc. with the FDA for Mega 5.5 Spine System.
| Device ID | K123476 |
| 510k Number | K123476 |
| Device Name: | MEGA 5.5 SPINE SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | LSK BIOPARTNERS, INC. 8 EAST BROADWAY, STE 611 Salt Lake City, UT 84111 |
| Contact | Shin Kuk Yoo |
| Correspondent | Shin Kuk Yoo LSK BIOPARTNERS, INC. 8 EAST BROADWAY, STE 611 Salt Lake City, UT 84111 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-13 |
| Decision Date | 2013-01-08 |
| Summary: | summary |