The following data is part of a premarket notification filed by Craniofacial Technologies, Inc. with the FDA for Ortholock Anchorage Devices.
| Device ID | K202691 |
| 510k Number | K202691 |
| Device Name: | Ortholock Anchorage Devices |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | Craniofacial Technologies, Inc. 98 Buckskin Road West Hills, CA 91307 |
| Contact | Kevin Kaveh |
| Correspondent | Michael Nilo Nilo Medical Consulting Group 3419 Denny Street Pittsburgh, PA 15201 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-15 |
| Decision Date | 2022-04-28 |