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FDA 510(k)

Calvary Spine Pedicle Screw System

K-Number: K201568 · 2020-11-12

ApplicantCalvary Spine, LLC
Decision Date2020-11-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Calvary Spine Pedicle Screw System is a medical device manufactured by Calvary Spine, LLC. It received FDA 510(k) clearance on 2020-11-12 under approval number K201568. 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 Calvary Spine Pedicle Screw System?

Calvary Spine Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2020-11-12. It is manufactured by Calvary Spine, LLC. The 510(k) number is K201568.

When was Calvary Spine Pedicle Screw System approved by the FDA?

Calvary Spine Pedicle Screw System received FDA 510(k) clearance on 2020-11-12, under approval number K201568.

What company makes Calvary Spine Pedicle Screw System?

Calvary Spine Pedicle Screw System is manufactured by Calvary Spine, LLC.

What is the FDA product code for Calvary Spine Pedicle Screw System?

The FDA product code for Calvary Spine Pedicle Screw System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07574632 A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis. 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)

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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