Class Class II
IdentiTi II Cervical Interbody System (K251080)
Description
IdentiTi II Cervical Interbody System by Alphatec Spine, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251080
Clearance Date2025-07-03
Clearance TypeTraditional
Product CodeODP
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251080
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. IdentiTi II Cervical Interbody System (K251080) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Inter... | Alphatec Spine | 2025 |
| K242364 | IdentiTi II Interbody System | Alphatec Spine, Inc. | 2024 |
| K151496 | Latitude-C Cervical Interbody Spacer System | Degen Medical | 2015 |
| K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015 |
Trace the full predicate network for K251080
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.