FDA 510(k)

SOLACE Sacroiliac Fixation System

Número K: K233241 · 2023-10-27

RequerenteHt Medical, LLC Dba Xenix Medical

Data da decisão2023-10-27

Código do produtoOUR

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SOLACE Sacroiliac Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Ht Medical, LLC Dba Xenix Medical. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K233241. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SOLACE Sacroiliac Fixation System?

SOLACE Sacroiliac Fixation System is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Ht Medical, LLC Dba Xenix Medical. The 510(k) number is K233241.

When did SOLACE Sacroiliac Fixation System receive FDA 510(k) clearance?

SOLACE Sacroiliac Fixation System received FDA 510(k) clearance on 2023-10-27, under 510(k) number K233241.

Who is the listed applicant for SOLACE Sacroiliac Fixation System?

The FDA 510(k) record lists Ht Medical, LLC Dba Xenix Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLACE Sacroiliac Fixation System?

The FDA product code for SOLACE Sacroiliac Fixation System is OUR.

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