FDA 510(k)

DRX9000C-SL Cervical Spinal Decompression System

Número K: K243366 · 2025-06-18

RequerenteExcite Medical of Tampa Bay, LLC

Data da decisão2025-06-18

Código do produtoITH

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Excite Medical of Tampa Bay, LLC como candidato(a)

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

Dispositivos Relacionados (Código: ITH)

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

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