Tigon Medical Fractures, Instability, and Reconstruction (FIRE) (K240175)
Description
Tigon Medical Fractures, Instability, and Reconstruction (FIRE) by Tigon Medical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240175
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. Tigon Medical Fractures, Instability, and Reconstruction (FIRE) (K240175) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K083096 | LATARJET CORTICAL SCREW SET | Tag Medical Products | 2009 |
| K052614 | LOW PROFILE PLATE AND SCREW SYSTEM | Arthrex, Inc. | 2005 |
Trace the full predicate network for K240175
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.