Class Class II

DRX9000C-SL Cervical Spinal Decompression System (K243366)

K243366 2025-06-18 Traditional
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Description

DRX9000C-SL Cervical Spinal Decompression System by Excite Medical of Tampa Bay, LLC, an FDA 510(k) cleared physical medicine device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK243366
Clearance Date2025-06-18
Clearance TypeTraditional
Product CodeITH
Regulation Number890.5900

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Predicate lineage for K243366

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. DRX9000C-SL Cervical Spinal Decompression System (K243366) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K023160DRX5000Axiom Usa., Inc.2002

Trace the full predicate network for K243366

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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