The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for The Gecko Spinal System.
| Device ID | K200281 |
| 510k Number | K200281 |
| Device Name: | The Gecko Spinal System |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | Ortho Development Corporation 12187 South Business Park Drive Draper, UT 84020 |
| Contact | Divya Palan |
| Correspondent | Divya Palan Ortho Development Corporation 12187 South Business Park Drive Draper, UT 84020 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-04 |
| Decision Date | 2020-03-31 |
| Summary: | summary |