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FDA 510(k)

Kisar Stratford SI Screw System

K-Number: K220274 · 2023-04-24

ApplicantAnjali Investments L.L.C
Decision Date2023-04-24
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kisar Stratford SI Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Anjali Investments L.L.C. It received FDA 510(k) clearance on 2023-04-24 under 510(k) number K220274. 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 Kisar Stratford SI Screw System?

Kisar Stratford SI Screw System is a medical device that received FDA 510(k) clearance on 2023-04-24. The listed applicant is Anjali Investments L.L.C. The 510(k) number is K220274.

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

Kisar Stratford SI Screw System received FDA 510(k) clearance on 2023-04-24, under 510(k) number K220274.

Who is the listed applicant for Kisar Stratford SI Screw System?

The FDA 510(k) record lists Anjali Investments L.L.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kisar Stratford SI Screw System?

The FDA product code for Kisar Stratford SI Screw 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.

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