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FDA 510(k)

DRX9000C-SL Cervical Spinal Decompression System

K-Number: K243366 · 2025-06-18

ApplicantExcite Medical of Tampa Bay, LLC
Decision Date2025-06-18
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DRX9000C-SL Cervical Spinal Decompression System is a medical device manufactured by Excite Medical of Tampa Bay, LLC. It received FDA 510(k) clearance on 2025-06-18 under approval number K243366. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRX9000C-SL Cervical Spinal Decompression System?

DRX9000C-SL Cervical Spinal Decompression System is a medical device that received FDA 510(k) clearance on 2025-06-18. It is manufactured by Excite Medical of Tampa Bay, LLC. The 510(k) number is K243366.

When was DRX9000C-SL Cervical Spinal Decompression System approved by the FDA?

DRX9000C-SL Cervical Spinal Decompression System received FDA 510(k) clearance on 2025-06-18, under approval number K243366.

What company makes DRX9000C-SL Cervical Spinal Decompression System?

DRX9000C-SL Cervical Spinal Decompression System is manufactured by Excite Medical of Tampa Bay, LLC.

What is the FDA product code for DRX9000C-SL Cervical Spinal Decompression System?

The FDA product code for DRX9000C-SL Cervical Spinal Decompression System is ITH.

Related Clinical Trials

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 26056630 Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. International journal of spine surgery (2015)

Other Devices by Excite Medical of Tampa Bay, LLC

K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)

Related Devices (Code: ITH)

K222912c1TracZimmer Medizinsysteme GmbH K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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