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FDA 510(k)

Siconus SI Joint Fixation System

K-Number: K162121 · 2017-01-18

ApplicantCamber Spine Technologies
Decision Date2017-01-18
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Siconus SI Joint Fixation System is a medical device manufactured by Camber Spine Technologies. It received FDA 510(k) clearance on 2017-01-18 under approval number K162121. 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 Siconus SI Joint Fixation System?

Siconus SI Joint Fixation System is a medical device that received FDA 510(k) clearance on 2017-01-18. It is manufactured by Camber Spine Technologies. The 510(k) number is K162121.

When was Siconus SI Joint Fixation System approved by the FDA?

Siconus SI Joint Fixation System received FDA 510(k) clearance on 2017-01-18, under approval number K162121.

What company makes Siconus SI Joint Fixation System?

Siconus SI Joint Fixation System is manufactured by Camber Spine Technologies.

What is the FDA product code for Siconus SI Joint Fixation System?

The FDA product code for Siconus SI Joint Fixation System is OUR.

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Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, 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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