The following data is part of a premarket notification filed by Gs Medical Co. Ltd. with the FDA for Pegasus-x Expandable Plif System.
| Device ID | K221687 |
| 510k Number | K221687 |
| Device Name: | Pegasus-X Expandable PLIF System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | GS Medical Co. Ltd. 90, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
| Contact | Sam Camp |
| Correspondent | Barry E. Sands RQMIS Inc. 110 Haverhill Road, Suite 524 Amesbury, MA 01913 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-10 |
| Decision Date | 2022-07-27 |