Class Class II

KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System (K233947)

K233947 2024-10-10 Traditional
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Description

KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System by Ctl Medical Corporation, an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK233947
Clearance Date2024-10-10
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080

Categories

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Predicate lineage for K233947

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. KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System (K233947) 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
K192115SABLE Expandable SpacerGlobus Medical, Inc.2020
K131981CEZANNE II INTERBODY FUSION SYSTEMAccel Spine2013

Trace the full predicate network for K233947

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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