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FDA 510(k)

SI Screw System

K-Number: K173752 · 2018-03-16

ApplicantZavation Medical Products, LLC
Decision Date2018-03-16
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SI Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K173752. 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 SI Screw System?

SI Screw System is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K173752.

When did SI Screw System receive FDA 510(k) clearance?

SI Screw System received FDA 510(k) clearance on 2018-03-16, under 510(k) number K173752.

Who is the listed applicant for SI Screw System?

The FDA 510(k) record lists Zavation Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SI Screw System?

The FDA product code for SI Screw System is OUR.

Other records listing Zavation Medical Products, LLC 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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