Class Class II
Caliber Intramedullary Fixation System (K242896)
Description
Caliber Intramedullary Fixation System by Nvision Biomedical Technologies, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242896
Clearance Date2025-02-05
Clearance TypeTraditional
Product CodeHWC
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242896
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. Caliber Intramedullary Fixation System (K242896) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182949 | Healix™ Compression Screw System | Nvision Biomedical Technologies, LLC | 2018 |
| K103001 | ROCKWOOD CLAVICLE PINS | DePuy Orthopaedics, Inc. | 2011 |
| K083144 | ACUMED CLAVICLE SCREW SYSTEM | Acumed, LLC | 2009 |
Trace the full predicate network for K242896
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.