Class Class II

OIC Variable Angle Small Fragment Locking Plate System (K223118)

K223118 2023-01-21 Traditional
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Description

OIC Variable Angle Small Fragment Locking Plate System by Orthopaedic Implant Company, an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK223118
Clearance Date2023-01-21
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030

Categories

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Predicate lineage for K223118

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 Variable Angle Small Fragment Locking Plate System (K223118) cites 3 predicate devices and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd.2018
K140357OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEMOrthopaedic Implant Company2014
K082072SYNTHES (USA) 3.5MM LCP HOOK PLATESynthes (Usa)2008

Later devices that cite this one as their predicate

Devices that cite K223118
K numberDeviceApplicantYear
K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company2024

Trace the full predicate network for K223118

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.

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