Class Class II
HAnano InterFuse(R) Modular Interbody (K242509)
Description
HAnano InterFuse(R) Modular Interbody by Next Orthosurgical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242509
Clearance Date2024-09-19
Clearance TypeSpecial
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242509
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. HAnano InterFuse(R) Modular Interbody (K242509) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222561 | Align | Acuity Surgical Devices, LLC | 2022 |
| K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | 2020 |
| K091988 | MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVIC... | Vertebral Technologies, Inc. | 2009 |
Trace the full predicate network for K242509
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.