Class Class II
PEEK Spinal Infusion Cage (K223776)
Description
PEEK Spinal Infusion Cage by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223776
Clearance Date2023-03-03
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223776
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. PEEK Spinal Infusion Cage (K223776) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K073291 | CAPSTONE SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2008 |
Trace the full predicate network for K223776
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.