Class Class II
Kisar Stratford SI Screw System (K220274)
Description
Kisar Stratford SI Screw System by Anjali Investments L.L.C, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220274
Clearance Date2023-04-24
Clearance TypeTraditional
Product CodeOUR
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220274
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. Kisar Stratford SI Screw System (K220274) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191748 | Genesys Spine Sacroiliac Joint Fusion System | Genesys Spine | 2019 |
| K152237 | The Entasis Dual-Lead Sacroiliac Implant | Corelink, LLC | 2016 |
| K021932 | SYNTHES 6.5 MM CANNULATED SCREW | Synthes (Usa) | 2002 |
Trace the full predicate network for K220274
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.