Class Class II

Apollo Knotless Suture Anchor (K230123)

K230123 2023-05-03 Traditional
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Description

Apollo Knotless Suture Anchor by Maruho Medical, an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK230123
Clearance Date2023-05-03
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040

Categories

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Predicate lineage for K230123

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. Apollo Knotless Suture Anchor (K230123) cites 3 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K220757Argo Knotless SP AnchorConmed Corporation2022
K192810Apollo Suture Anchor SystemValeris Medical2020
K133036APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWSAmendia, Inc.2014

Trace the full predicate network for K230123

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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