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FDA 510(k)

CASSATT™ SIJ Fixation System

K-Number: K211785 · 2022-10-17

ApplicantCtl Medical Corporation
Decision Date2022-10-17
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CASSATT™ SIJ Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Ctl Medical Corporation. It received FDA 510(k) clearance on 2022-10-17 under 510(k) number K211785. 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 CASSATT™ SIJ Fixation System?

CASSATT™ SIJ Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-17. The listed applicant is Ctl Medical Corporation. The 510(k) number is K211785.

When did CASSATT™ SIJ Fixation System receive FDA 510(k) clearance?

CASSATT™ SIJ Fixation System received FDA 510(k) clearance on 2022-10-17, under 510(k) number K211785.

Who is the listed applicant for CASSATT™ SIJ Fixation System?

The FDA 510(k) record lists Ctl Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CASSATT™ SIJ Fixation System?

The FDA product code for CASSATT™ SIJ Fixation System is OUR.

Other records listing Ctl Medical Corporation as applicant

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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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