Joints 5.35
Joints 5.35 is a Class II device made by Medstrat, Inc., cleared under FDA 510(k) K051745 on 14 Jul 2005 and listed in FDA GUDID since 20 Jan 2023 (UDI-DI 00817886020486), 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 | Number00817886020486 | Date20 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051745 | Date14 Jul 2005 | StatusActive |
Official records
- AccessGUDID record 00817886020486
- FDA 510(k) database K051745
Across registries
- FDA 510(k) K051745 decided 14 Jul 2005 Active
- FDA GUDID UDI-DI 00817886020486 listed 20 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K051745
- Listed FDA GUDID 00817886020486
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Joints
- Generic name
- Radiological PACS-dedicated management software
- Model / reference
- 5.35
- Primary DI / UDI-DI
- 00817886020486
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiological PACS-dedicated management software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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