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FDA 510(k)

Release Laminoplasty Fixation System

K-Number: K153735 · 2016-01-21

ApplicantPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Decision Date2016-01-21
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Release Laminoplasty Fixation System is a medical device manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It received FDA 510(k) clearance on 2016-01-21 under approval number K153735. 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 Release Laminoplasty Fixation System?

Release Laminoplasty Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-21. It is manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K153735.

When was Release Laminoplasty Fixation System approved by the FDA?

Release Laminoplasty Fixation System received FDA 510(k) clearance on 2016-01-21, under approval number K153735.

What company makes Release Laminoplasty Fixation System?

Release Laminoplasty Fixation System is manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.).

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

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

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Other Devices by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

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Related Devices (Code: NQW)

K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, 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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