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FDA 510(k)

SurgTech Thoracolumbosacral (TLS) Posterior Fixation System

K-Number: K163363 · 2017-04-05

ApplicantSurgtech, Inc.
Decision Date2017-04-05
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SurgTech Thoracolumbosacral (TLS) Posterior Fixation System is a medical device manufactured by Surgtech, Inc.. It received FDA 510(k) clearance on 2017-04-05 under approval number K163363. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgTech Thoracolumbosacral (TLS) Posterior Fixation System?

SurgTech Thoracolumbosacral (TLS) Posterior Fixation System is a medical device that received FDA 510(k) clearance on 2017-04-05. It is manufactured by Surgtech, Inc.. The 510(k) number is K163363.

When was SurgTech Thoracolumbosacral (TLS) Posterior Fixation System approved by the FDA?

SurgTech Thoracolumbosacral (TLS) Posterior Fixation System received FDA 510(k) clearance on 2017-04-05, under approval number K163363.

What company makes SurgTech Thoracolumbosacral (TLS) Posterior Fixation System?

SurgTech Thoracolumbosacral (TLS) Posterior Fixation System is manufactured by Surgtech, Inc..

What is the FDA product code for SurgTech Thoracolumbosacral (TLS) Posterior Fixation System?

The FDA product code for SurgTech Thoracolumbosacral (TLS) Posterior Fixation System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA 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 NCT07527299 A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation NOT_YET_RECRUITING NCT02839850 14022 ATTUNE Cementless RP Clinical Performance Evaluation ACTIVE_NOT_RECRUITING

Other Devices by Surgtech, Inc.

K152200SurgTech Interbody System K162125MALUC™ Total Hip Arthroplasty System K161894SurgTech Trauma System K173455SurgTech Bipolar Head System K191192SurgTech GENOLL Total Knee System

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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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