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FDA 510(k)

Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System

K-Number: K160020 · 2016-03-02

ApplicantCaptiva Spine
Decision Date2016-03-02
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System is a medical device manufactured by Captiva Spine. It received FDA 510(k) clearance on 2016-03-02 under approval number K160020. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System?

Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-03-02. It is manufactured by Captiva Spine. The 510(k) number is K160020.

When was Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System approved by the FDA?

Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System received FDA 510(k) clearance on 2016-03-02, under approval number K160020.

What company makes Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System?

Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System is manufactured by Captiva Spine.

What is the FDA product code for Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System?

The FDA product code for Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System is MNH. This falls under the ENT category.

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: MNH)

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. K162143FixxSure® X-LinkInnovasis, Inc. K161151Spinal fixation systemCanwell Medical Co., Ltd. K162189ANAX™ 5.5 Spinal SystemU&I Corporation K151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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