Class Class II

Cervical Spine Truss System (CSTS) Interbody Fusion Device (K221266)

K221266 2023-01-05 Traditional
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Description

Cervical Spine Truss System (CSTS) Interbody Fusion Device by 4Web Medical, Inc., an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK221266
Clearance Date2023-01-05
Clearance TypeTraditional
Product CodeODP
Regulation Number888.3080

Categories

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Predicate lineage for K221266

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. Cervical Spine Truss System (CSTS) Interbody Fusion Device (K221266) 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
K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.2019
K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.2018

Trace the full predicate network for K221266

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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