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FDA 510(k)

SOLACE Sacroiliac Fixation System

K-Number: K233241 · 2023-10-27

ApplicantHt Medical, LLC Dba Xenix Medical
Decision Date2023-10-27
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: OUR)

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.

K260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys Spine

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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