Class Class II
Montage-XT Settable, Resorbable Bone Putty (K233566)
Description
Montage-XT Settable, Resorbable Bone Putty by Orthocon, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233566
Clearance Date2024-08-21
Clearance TypeTraditional
Product CodeMQV
Regulation Number888.3045
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233566
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-XT Settable, Resorbable Bone Putty (K233566) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222063 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | 2023 |
| K220315 | MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243506 | Montage-XT Settable Bone Putty | Orthocon, Inc. | 2024 |
Trace the full predicate network for K233566
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.