T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (K251400)
Description
T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System by Stryker GmbH, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251400
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. T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (K251400) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230352 | Tornier Humeral Nail and Tornier Long Humeral Nail | Tornier, Inc. | 2023 |
| K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial ... | Stryker GmbH | 2022 |
| K032523 | T2 NAILING SYSTEM | Howmedica Osteonics Corp. | 2003 |
Trace the full predicate network for K251400
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.