FDA 510(k)

The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems

K-Number: K170942 · 2017-04-26

Decision Date2017-04-26

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems is a medical device manufactured by Choicespine, LP. It received FDA 510(k) clearance on 2017-04-26 under approval number K170942. 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 The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems?

The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems is a medical device that received FDA 510(k) clearance on 2017-04-26. It is manufactured by Choicespine, LP. The 510(k) number is K170942.

When was The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems approved by the FDA?

The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems received FDA 510(k) clearance on 2017-04-26, under approval number K170942.

What company makes The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems?

The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems is manufactured by Choicespine, LP.

What is the FDA product code for The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems?

The FDA product code for The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems is NKB.

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Related PubMed Literature

PMID: 41886403 Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990 to 2023. Urology practice (2026) PMID: 41518328 Surface Energy and Pinning Forces of Fluorine-Free, Water-Friendly Coatings for Medical Devices. Langmuir : the ACS journal of surfaces and colloids (2026) PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025) PMID: 40856794 [Translational challenges and clinical potential of artificial intelligence in minimally invasive surgery]. Chirurgie (Heidelberg, Germany) (2025)

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 K170953Tomcat Cervical Spinal System

View all 14 devices →

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.