Class Class II
MONTAGE Settable, Resorbable Bone Putty (K221933)
Description
MONTAGE Settable, Resorbable Bone Putty by Orthocon, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221933
Clearance Date2023-01-13
Clearance TypeTraditional
Product CodeGXP
Regulation Number882.5300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221933
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. MONTAGE Settable, Resorbable Bone Putty (K221933) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K060763 | STRYKER INJECTABLE CEMENT | Stryker | 2006 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231475 | MONTAGE-QS Settable, Resorbable Bone Putty | Orthocon, Inc. | 2023 |
Trace the full predicate network for K221933
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.