OrthoNext™ Platform System Software 1.0
OrthoNext™ Platform System Software 1.0 (TLHEXMODULESW) is a Class II device made by Orthofix SRL, cleared under FDA 510(k) K202519 on 27 Oct 2020 and listed in FDA GUDID since 31 Mar 2023 (UDI-DI 18052469476444), 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 | Number18052469476444 | Date31 Mar 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202519 | Date27 Oct 2020 | StatusActive |
Official records
- AccessGUDID record 18052469476444
- FDA 510(k) database K202519
Across registries
- FDA 510(k) K202519 decided 27 Oct 2020 Active
- FDA GUDID UDI-DI 18052469476444 listed 31 Mar 2023 Listed
Timeline
- Cleared FDA 510(k) K202519
- Listed FDA GUDID 18052469476444
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- Withdrawn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
- 1.0, TLHEXMODULESW
- Primary DI / UDI-DI
- 18052469476444
- 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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