Class Class II
Permatage Settable Bone Putty (K241027)
Description
Permatage Settable Bone Putty by Orthocon, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241027
Clearance Date2024-09-26
Clearance TypeTraditional
Product CodeGXP
Regulation Number882.5300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241027
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. Permatage Settable Bone Putty (K241027) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202363 | HBP7 Settable Hemostatic Bone Putty | Orthocon, Inc. | 2021 |
| K060763 | STRYKER INJECTABLE CEMENT | Stryker | 2006 |
Trace the full predicate network for K241027
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.