The following data is part of a premarket notification filed by Edisoninno Co., Ltd. with the FDA for Unispace Sa Cervical Cage.
| Device ID | K213791 |
| 510k Number | K213791 |
| Device Name: | Unispace SA Cervical Cage |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Edisoninno Co., Ltd. 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
| Contact | So-yeon Jang |
| Correspondent | So-Yeon Jang Edisoninno Co., Ltd. 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 11781 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-06 |
| Decision Date | 2022-08-05 |