Class Class II

Orthopeasia Spinal Fixation System (K240180)

K240180 2024-08-30 Traditional
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Description

Orthopeasia Spinal Fixation System by Orthopeasia Co., Ltd., an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK240180
Clearance Date2024-08-30
Clearance TypeTraditional
Product CodeNKB
Regulation Number888.3070

Categories

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Predicate lineage for K240180

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. Orthopeasia Spinal Fixation System (K240180) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.2020
K130932FIREBIRD SPINAL FIXATION SYSTEMOrthofix, Inc.2013

Trace the full predicate network for K240180

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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