OrthoNext™ Platform System Software 1.1
OrthoNext™ Platform System Software 1.1 (TLHEXMODULESW1.1) is a Class II device made by Orthofix SRL, cleared under FDA 510(k) K242270 on 19 Dec 2024 and listed in FDA GUDID since 31 Jan 2025 (UDI-DI 18059015375848), active as of 12 Nov 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 | Number18059015375848 | Date31 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK242270 | Date19 Dec 2024 | StatusActive |
Official records
- AccessGUDID record 18059015375848
- FDA 510(k) database K242270
Across registries
- FDA 510(k) K242270 decided 19 Dec 2024 Active
- FDA GUDID UDI-DI 18059015375848 listed 31 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K242270
- Listed FDA GUDID 18059015375848
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OrthoNext™ Platform System Software
- Generic name
- Radiological PACS-dedicated management software
- Model / Ref / Catalog
- 1.1, TLHEXMODULESW1.1
- Primary DI / UDI-DI
- 18059015375848
- 510(k) Number
- FDA product code
- QIH
- 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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