Class Class II
CONDUIT™ SYNFIX™ Evolution Secured Spacer System (K250072)
Description
CONDUIT™ SYNFIX™ Evolution Secured Spacer System by Avalign Technologies, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250072
Clearance Date2025-07-10
Clearance TypeTraditional
Product CodeOVD
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250072
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. CONDUIT™ SYNFIX™ Evolution Secured Spacer System (K250072) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201585 | Monterey AL Interbody System | Stryker Corporation | 2020 |
| K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ... | Eit Emerging Implant Technologies GmbH | 2020 |
| K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ... | Eit Emerging Implant Technologies GmbH | 2017 |
| K150673 | SYNFIX Evolution Secured Spacer System | Synthes (USA) Products, LLC | 2015 |
Trace the full predicate network for K250072
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.