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FDA 510(k)

Harvester SI: Sacroiliac Fixation System

K-Number: K203780 · 2021-03-23

ApplicantSpinus International, Inc.
Decision Date2021-03-23
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Harvester SI: Sacroiliac Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Spinus International, Inc.. It received FDA 510(k) clearance on 2021-03-23 under 510(k) number K203780. 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 Harvester SI: Sacroiliac Fixation System?

Harvester SI: Sacroiliac Fixation System is a medical device that received FDA 510(k) clearance on 2021-03-23. The listed applicant is Spinus International, Inc.. The 510(k) number is K203780.

When did Harvester SI: Sacroiliac Fixation System receive FDA 510(k) clearance?

Harvester SI: Sacroiliac Fixation System received FDA 510(k) clearance on 2021-03-23, under 510(k) number K203780.

Who is the listed applicant for Harvester SI: Sacroiliac Fixation System?

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

What is the FDA product code for Harvester SI: Sacroiliac Fixation System?

The FDA product code for Harvester SI: Sacroiliac Fixation 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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