Ijs-E
by Skeletal Dynamics L.L.C. 7 variants
Ijs-E (IJS-DBL-BPA) is a Class II device made by Skeletal Dynamics L.L.C., cleared under FDA 510(k) K153208 on 31 Dec 2015 and listed in FDA GUDID since 20 Jun 2023 (UDI-DI 00841506109138), active as of 21 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 | Number00841506109138 | Date20 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153208 | Date31 Dec 2015 | StatusActive |
Official records
- AccessGUDID record 00841506109138
- FDA 510(k) database K153208
Across registries
- FDA 510(k) K153208 decided 31 Dec 2015 Active
- FDA GUDID UDI-DI 00841506109138 listed 20 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K153208
- Listed FDA GUDID 00841506109138
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Elbow stabilization implant
- Model / Ref / Catalog
- IJS, IJS-DBL-BPA
- Primary DI / UDI-DI
- 00841506109138
- 510(k) Number
- FDA product code
- OZI, LXT
- GMDN term
- Elbow stabilization implant
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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