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FDA 510(k)

SambaScrew 3D SI Fusion System

K-Number: K183342 · 2019-04-30

ApplicantOrthofix, Inc.
Decision Date2019-04-30
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SambaScrew 3D SI Fusion System is a medical device manufactured by Orthofix, Inc.. It received FDA 510(k) clearance on 2019-04-30 under approval number K183342. 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 SambaScrew 3D SI Fusion System?

SambaScrew 3D SI Fusion System is a medical device that received FDA 510(k) clearance on 2019-04-30. It is manufactured by Orthofix, Inc.. The 510(k) number is K183342.

When was SambaScrew 3D SI Fusion System approved by the FDA?

SambaScrew 3D SI Fusion System received FDA 510(k) clearance on 2019-04-30, under approval number K183342.

What company makes SambaScrew 3D SI Fusion System?

SambaScrew 3D SI Fusion System is manufactured by Orthofix, Inc..

What is the FDA product code for SambaScrew 3D SI Fusion System?

The FDA product code for SambaScrew 3D SI Fusion System is OUR.

Related Clinical Trials

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Other Devices by Orthofix, Inc.

K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System K162638CETRA Anterior Cervical Plate System K161129PILLAR SA PTC K161280Cervical Stand Alone System K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System K152475FORZA PTC Spacer System

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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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