FDA 510(k)

Choice Spine Laminoplasty Fixation System

K-Number: K173215 · 2018-01-19

Decision Date2018-01-19

Product CodeNQW

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Choice Spine Laminoplasty Fixation System is a medical device manufactured by Choicespine, LP. It received FDA 510(k) clearance on 2018-01-19 under approval number K173215. 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 Choice Spine Laminoplasty Fixation System?

Choice Spine Laminoplasty Fixation System is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Choicespine, LP. The 510(k) number is K173215.

When was Choice Spine Laminoplasty Fixation System approved by the FDA?

Choice Spine Laminoplasty Fixation System received FDA 510(k) clearance on 2018-01-19, under approval number K173215.

What company makes Choice Spine Laminoplasty Fixation System?

Choice Spine Laminoplasty Fixation System is manufactured by Choicespine, LP.

What is the FDA product code for Choice Spine Laminoplasty Fixation System?

The FDA product code for Choice Spine Laminoplasty Fixation System is NQW.

Related Clinical Trials

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Other Devices by Choicespine, LP

K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye) K160775Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems K153107Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System K171489Acapella Cervical Spacer System K170821ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System K170942The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems

View all 14 devices →

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. K181717Life Spine Laminoplasty SystemLife Spine, Inc. 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.