OrthoFit
by Spident
510(k) K261129
OrthoFit is a Class II device made by Spident, cleared under FDA 510(k) K261129 on 2 Jul 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK261129 | Date2 Jul 2026 | StatusActive |
Official records
- FDA 510(k) database K261129
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DYH
- FDA applicant
- Spident Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3750
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K261129
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| OrthoFit Bond 2ea | OrthoFit Bond 2ea | 08809262957983 | — | On the market |
| OrthoFit Bond mini | OrthoFit Bond mini | 08809262950823 | — | On the market |
| OrthoFit Splint | OrthoFit Splint | 08809262957990 | — | On the market |