OrthoNext Platform System
510(k) K242270
OrthoNext Platform System is a Class II device made by Orthofix SRL, cleared under FDA 510(k) K242270 on 19 Dec 2024, 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 | FDA 510(k)SESE | NumberK242270 | Date19 Dec 2024 | StatusActive |
Official records
- FDA 510(k) database K242270
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K242270
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ORTHOFIX MODULSYSTEM 1 | 99-MIL10 / 1 | 18052469470008 | On the market | |
| OrthoNext™ Platform System Software 1.1 | JPSMODULESW / 1.1 | 18053340345682 | On the market | |
| OrthoNext™ Platform System Software 1.1 | TLHEXMODULESW1.1 / 1.1 | 18059015375848 | On the market | |
| OrthoNext™ Platform System Software 2.1 | ORTHONEXTSW2.1 / 2.1 | 18059015375831 | On the market |
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