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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 the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2019-04-30 under 510(k) 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. The listed applicant is Orthofix, Inc.. The 510(k) number is K183342.

When did SambaScrew 3D SI Fusion System receive FDA 510(k) clearance?

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

Who is the listed applicant for SambaScrew 3D SI Fusion System?

The FDA 510(k) record lists Orthofix, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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NCT07282067Orthofix PhysioStim PEMF Ankle Fusion RetrospectiveACTIVE_NOT_RECRUITING

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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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