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FDA 510(k)

SILEX SACROILIAC JOINT FUSION SYSTEM

K-Number: K123702 · 2013-03-11

ApplicantX-Spine Systems, Inc.
Decision Date2013-03-11
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SILEX SACROILIAC JOINT FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2013-03-11 under 510(k) number K123702. 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 SILEX SACROILIAC JOINT FUSION SYSTEM?

SILEX SACROILIAC JOINT FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-11. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K123702.

When did SILEX SACROILIAC JOINT FUSION SYSTEM receive FDA 510(k) clearance?

SILEX SACROILIAC JOINT FUSION SYSTEM received FDA 510(k) clearance on 2013-03-11, under 510(k) number K123702.

Who is the listed applicant for SILEX SACROILIAC JOINT FUSION SYSTEM?

The FDA 510(k) record lists X-Spine Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILEX SACROILIAC JOINT FUSION SYSTEM?

The FDA product code for SILEX SACROILIAC JOINT FUSION SYSTEM is OUR.

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Other records listing X-Spine Systems, Inc. as applicant

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K173832InTice™-C Porous Ti Cervical Interbody SystemK180153X-spine Cortical Bone Screw SystemK170119Calix Lumbar Spinal Implant SystemK171567IRIX-A Lumbar Integrated Fusion SystemK171075Calix-C Cervical Interbody SpacerK170224Spider Cervical Plating System

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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.

K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLCK260477CATAMARAN™ 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, LLC

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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