FDA 510(k)

Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems

K-Number: K160775 · 2016-06-03

Decision Date2016-06-03

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems is a medical device manufactured by Choicespine, LP. It received FDA 510(k) clearance on 2016-06-03 under approval number K160775. 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 Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems?

Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems is a medical device that received FDA 510(k) clearance on 2016-06-03. It is manufactured by Choicespine, LP. The 510(k) number is K160775.

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

Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems received FDA 510(k) clearance on 2016-06-03, under approval number K160775.

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

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

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

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

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07385508 Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches RECRUITING NCT07557589 Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months RECRUITING NCT05053555 High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies RECRUITING NCT07605234 Phase II Single Arm Open Label Study Evaluating the Feasibility and Safety of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients With Hematolymphoid Malignancies NOT_YET_RECRUITING

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) 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 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.