The following data is part of a premarket notification filed by Evolution Spine with the FDA for Emerge Anterior Cervical Plate System.
| Device ID | K220275 |
| 510k Number | K220275 |
| Device Name: | EMERGE Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Evolution Spine 2300 N. Haskell Ave Dallas, TX 75204 |
| Contact | Todd Wallenstein |
| Correspondent | Todd Wallenstein Evolution Spine 2300 N. Haskell Ave Dallas, TX 75204 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195860016268 | K220275 | 000 |
| 00195860016114 | K220275 | 000 |
| 00195860016121 | K220275 | 000 |
| 00195860016138 | K220275 | 000 |
| 00195860016145 | K220275 | 000 |
| 00195860016152 | K220275 | 000 |
| 00195860016169 | K220275 | 000 |
| 00195860016176 | K220275 | 000 |
| 00195860016183 | K220275 | 000 |
| 00195860016190 | K220275 | 000 |
| 00195860016206 | K220275 | 000 |
| 00195860016213 | K220275 | 000 |
| 00195860016220 | K220275 | 000 |
| 00195860016237 | K220275 | 000 |
| 00195860016244 | K220275 | 000 |
| 00195860016251 | K220275 | 000 |
| 00195860016107 | K220275 | 000 |