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FDA 510(k)

Harvester SI: Sacroiliac Fixation System

K-Number: K203780 · 2021-03-23

ApplicantSpinus International, Inc.
Decision Date2021-03-23
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Harvester SI: Sacroiliac Fixation System is a medical device manufactured by Spinus International, Inc.. It received FDA 510(k) clearance on 2021-03-23 under approval number K203780. 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 Harvester SI: Sacroiliac Fixation System?

Harvester SI: Sacroiliac Fixation System is a medical device that received FDA 510(k) clearance on 2021-03-23. It is manufactured by Spinus International, Inc.. The 510(k) number is K203780.

When was Harvester SI: Sacroiliac Fixation System approved by the FDA?

Harvester SI: Sacroiliac Fixation System received FDA 510(k) clearance on 2021-03-23, under approval number K203780.

What company makes Harvester SI: Sacroiliac Fixation System?

Harvester SI: Sacroiliac Fixation System is manufactured by Spinus International, Inc..

What is the FDA product code for Harvester SI: Sacroiliac Fixation System?

The FDA product code for Harvester SI: Sacroiliac Fixation System is OUR.

Related Clinical Trials

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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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