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FDA 510(k)

Life Spine Laminoplasty System

K-Number: K181717 · 2018-10-12

ApplicantLife Spine, Inc.
Decision Date2018-10-12
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Life Spine Laminoplasty System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2018-10-12 under approval number K181717. 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 Life Spine Laminoplasty System?

Life Spine Laminoplasty System is a medical device that received FDA 510(k) clearance on 2018-10-12. It is manufactured by Life Spine, Inc.. The 510(k) number is K181717.

When was Life Spine Laminoplasty System approved by the FDA?

Life Spine Laminoplasty System received FDA 510(k) clearance on 2018-10-12, under approval number K181717.

What company makes Life Spine Laminoplasty System?

Life Spine Laminoplasty System is manufactured by Life Spine, Inc..

What is the FDA product code for Life Spine Laminoplasty System?

The FDA product code for Life Spine Laminoplasty System is NQW.

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Other Devices by Life Spine, Inc.

K161127The Small PLATEAU (PLATEAU-C) Spacer System K160066Pro-Link® Stand-Alone Cervical Spacer System K161037Tarsa-Link Stand-Alone Wedge Fixation System K153065The Hammertoe Correction System K153400ProLift Expandable System K172973Life Spine Foot and Ankle Plating System

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Related Devices (Code: NQW)

K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc. K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, 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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