Class Class II
OIC Intramedullary Screw System (K223761)
Description
OIC Intramedullary Screw System by Orthopaedic Implant Company, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223761
Clearance Date2023-02-13
Clearance TypeTraditional
Product CodeHWC
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223761
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. OIC Intramedullary Screw System (K223761) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183603 | INnate Cannulated Screw System | Exsomed Corporation | 2019 |
| K181184 | OIC Intramedullary Nail System | The Orthopaedic Implant Company | 2018 |
| K113123 | OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SY... | The Orthopaedic Implant Company | 2012 |
| K050636 | SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS | Synthes (Usa) | 2005 |
Trace the full predicate network for K223761
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.