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FDA 510(k)

Xspan Laminoplasty Fixation System

K-Number: K160114 · 2016-03-15

ApplicantX-Spine Systems, Inc.
Decision Date2016-03-15
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xspan Laminoplasty Fixation System is a medical device manufactured by X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2016-03-15 under approval number K160114. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xspan Laminoplasty Fixation System?

Xspan Laminoplasty Fixation System is a medical device that received FDA 510(k) clearance on 2016-03-15. It is manufactured by X-Spine Systems, Inc.. The 510(k) number is K160114.

When was Xspan Laminoplasty Fixation System approved by the FDA?

Xspan Laminoplasty Fixation System received FDA 510(k) clearance on 2016-03-15, under approval number K160114.

What company makes Xspan Laminoplasty Fixation System?

Xspan Laminoplasty Fixation System is manufactured by X-Spine Systems, Inc..

What is the FDA product code for Xspan Laminoplasty Fixation System?

The FDA product code for Xspan Laminoplasty Fixation System is NQW.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT07079774 TrueLok Elevate PMCF Study RECRUITING

Other Devices by X-Spine Systems, Inc.

K160959Xsert Lumbar Expandable Interbody System K162944Irix-C Cervical Integrated Fusion System K160428Certex Spinal Fixation System K170119Calix Lumbar Spinal Implant System K171567IRIX-A Lumbar Integrated Fusion System K171075Calix-C Cervical Interbody Spacer

View all 11 devices →

Related Devices (Code: NQW)

K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc. K181717Life Spine Laminoplasty SystemLife Spine, Inc. K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP K191927Hinged Laminoplasty SystemLife Spine, Inc. K191169NuVasive® Camber Laminoplasty SystemNu Vasive, Incorporated

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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