The following data is part of a premarket notification filed by Bespoke Technologies, Llc with the FDA for Tailored-h Cervical Stand Alone System.
| Device ID | K222903 |
| 510k Number | K222903 |
| Device Name: | Tailored-H Cervical Stand Alone System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | BeSpoke Technologies, LLC 118 S. Cherry St, Suite E Winston-Salemn, NC 27101 |
| Contact | Daniel Hoehn |
| Correspondent | Nathan Wright BeSpoke Technologies, LLC 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-23 |
| Decision Date | 2022-11-18 |