FDA 510(k)

ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System

K-Number: K170821 · 2017-06-08

Decision Date2017-06-08

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System is a medical device manufactured by Choicespine, LP. It received FDA 510(k) clearance on 2017-06-08 under approval number K170821. 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 ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System?

ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System is a medical device that received FDA 510(k) clearance on 2017-06-08. It is manufactured by Choicespine, LP. The 510(k) number is K170821.

When was ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System approved by the FDA?

ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System received FDA 510(k) clearance on 2017-06-08, under approval number K170821.

What company makes ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System?

ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System is manufactured by Choicespine, LP.

What is the FDA product code for ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System?

The FDA product code for ChoiceSpine Proliant® Posterior Pedicle Screw and Hook 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 NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_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

Related PubMed Literature

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)

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 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.