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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 the device name listed in this FDA 510(k) record. The listed applicant is Excite Medical of Tampa Bay, LLC. It received FDA 510(k) clearance on 2025-06-18 under 510(k) 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. The listed applicant is Excite Medical of Tampa Bay, LLC. The 510(k) number is K243366.

When did DRX9000C-SL Cervical Spinal Decompression System receive FDA 510(k) clearance?

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

Who is the listed applicant for DRX9000C-SL Cervical Spinal Decompression System?

The FDA 510(k) record lists Excite Medical of Tampa Bay, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Excite Medical of Tampa Bay, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: ITH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLCK214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLCK222912c1TracZimmer Medizinsysteme GmbH

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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