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FDA 510(k)

AXIS 5.5 Lumbar Pedicle Screw System

K-Number: K180301 · 2018-04-10

ApplicantAxis Orthopaedics
Decision Date2018-04-10
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AXIS 5.5 Lumbar Pedicle Screw System is a medical device manufactured by Axis Orthopaedics. It received FDA 510(k) clearance on 2018-04-10 under approval number K180301. 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 AXIS 5.5 Lumbar Pedicle Screw System?

AXIS 5.5 Lumbar Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2018-04-10. It is manufactured by Axis Orthopaedics. The 510(k) number is K180301.

When was AXIS 5.5 Lumbar Pedicle Screw System approved by the FDA?

AXIS 5.5 Lumbar Pedicle Screw System received FDA 510(k) clearance on 2018-04-10, under approval number K180301.

What company makes AXIS 5.5 Lumbar Pedicle Screw System?

AXIS 5.5 Lumbar Pedicle Screw System is manufactured by Axis Orthopaedics.

What is the FDA product code for AXIS 5.5 Lumbar Pedicle Screw System?

The FDA product code for AXIS 5.5 Lumbar 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 NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) 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 NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs 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 Axis Orthopaedics

K181140Axis Chena Cervical PEEK Spacer System K173867Axis Anterior Cervical Plate System

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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