Unity Erodium 000E011545
Unity Erodium 000E011545 is a Class II device made by Dio Medical Co., Ltd., cleared under FDA 510(k) K222448 on 13 Oct 2022 and listed in FDA GUDID since 26 Jun 2023 (UDI-DI 00850051372034), 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 | GUDID listing | Number00850051372034 | Date26 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222448 | Date13 Oct 2022 | StatusActive |
Official records
- AccessGUDID record 00850051372034
- FDA 510(k) database K222448
Across registries
- FDA 510(k) K222448 decided 13 Oct 2022 Active
- FDA GUDID UDI-DI 00850051372034 listed 26 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K222448
- Listed FDA GUDID 00850051372034
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Unity Erodium
- Generic name
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
- Model / Ref / Catalog
- 000E011545
- Primary DI / UDI-DI
- 00850051372034
- 510(k) Number
- FDA product code
- OUR
- GMDN term
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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