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)

SIros-X System

K-Number: K252322 · 2025-10-22

ApplicantGenesys Spine
Decision Date2025-10-22
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIros-X System is the device name listed in this FDA 510(k) record. The listed applicant is Genesys Spine. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K252322. 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 SIros-X System?

SIros-X System is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Genesys Spine. The 510(k) number is K252322.

When did SIros-X System receive FDA 510(k) clearance?

SIros-X System received FDA 510(k) clearance on 2025-10-22, under 510(k) number K252322.

Who is the listed applicant for SIros-X System?

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

What is the FDA product code for SIros-X System?

The FDA product code for SIros-X System is OUR.

Other records listing Genesys Spine as applicant

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.

K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemK233595Genesys Spine Sacroiliac Joint Fusion System with NavigationK233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemK220096Genesys Spine 3DP Lumbar Interbody SystemK191489Genesys Spine 3DP Cervical Interbody SystemK182987Genesys Spine 3DP Lumbar Interbody System

View all 21 devices →

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, LLCK253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.

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.

↑