Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Integrity-SI TM Fusion System

K-Number: K161755 · 2016-12-14

ApplicantCoorstek Medical
Decision Date2016-12-14
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Integrity-SI TM Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Coorstek Medical. It received FDA 510(k) clearance on 2016-12-14 under 510(k) number K161755. 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 Integrity-SI TM Fusion System?

Integrity-SI TM Fusion System is a medical device that received FDA 510(k) clearance on 2016-12-14. The listed applicant is Coorstek Medical. The 510(k) number is K161755.

When did Integrity-SI TM Fusion System receive FDA 510(k) clearance?

Integrity-SI TM Fusion System received FDA 510(k) clearance on 2016-12-14, under 510(k) number K161755.

Who is the listed applicant for Integrity-SI TM Fusion System?

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

What is the FDA product code for Integrity-SI TM Fusion System?

The FDA product code for Integrity-SI TM Fusion System is OUR.

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.

↑