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FDA 510(k)

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

K-Number: K243775 · 2025-07-18

ApplicantExcite Medical of Tampa Bay, LLC
Decision Date2025-07-18
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

True Non-Surgical Spinal Decompression System (DRX9000-SL) is a medical device manufactured by Excite Medical of Tampa Bay, LLC. It received FDA 510(k) clearance on 2025-07-18 under approval number K243775. 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 True Non-Surgical Spinal Decompression System (DRX9000-SL)?

True Non-Surgical Spinal Decompression System (DRX9000-SL) is a medical device that received FDA 510(k) clearance on 2025-07-18. It is manufactured by Excite Medical of Tampa Bay, LLC. The 510(k) number is K243775.

When was True Non-Surgical Spinal Decompression System (DRX9000-SL) approved by the FDA?

True Non-Surgical Spinal Decompression System (DRX9000-SL) received FDA 510(k) clearance on 2025-07-18, under approval number K243775.

What company makes True Non-Surgical Spinal Decompression System (DRX9000-SL)?

True Non-Surgical Spinal Decompression System (DRX9000-SL) is manufactured by Excite Medical of Tampa Bay, LLC.

What is the FDA product code for True Non-Surgical Spinal Decompression System (DRX9000-SL)?

The FDA product code for True Non-Surgical Spinal Decompression System (DRX9000-SL) is ITH.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Excite Medical of Tampa Bay, LLC

K243366DRX9000C-SL Cervical Spinal Decompression System

Related Devices (Code: ITH)

K222912c1TracZimmer Medizinsysteme GmbH K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC K243366DRX9000C-SL Cervical Spinal Decompression SystemExcite 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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