Class Class II
GaiaBone Bioabsorbable Bone Graft (K220337)
Description
GaiaBone Bioabsorbable Bone Graft by Corliber (Shenzhen) Medical Device Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220337
Clearance Date2023-02-03
Clearance TypeTraditional
Product CodeMQV
Regulation Number888.3045
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220337
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. GaiaBone Bioabsorbable Bone Graft (K220337) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K141725 | BONGOLD BONE GRAFT MATERIAL | Beijing Allgens Medical Science & T... | 2015 |
Trace the full predicate network for K220337
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.