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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 the device name listed in this FDA 510(k) record. The listed applicant is Axis Orthopaedics. It received FDA 510(k) clearance on 2018-04-10 under 510(k) 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. The listed applicant is Axis Orthopaedics. The 510(k) number is K180301.

When did AXIS 5.5 Lumbar Pedicle Screw System receive FDA 510(k) clearance?

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

Who is the listed applicant for AXIS 5.5 Lumbar Pedicle Screw System?

The FDA 510(k) record lists Axis Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITINGNCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITING

Other records listing Axis Orthopaedics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181140Axis Chena Cervical PEEK Spacer SystemK173867Axis Anterior Cervical Plate System

Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak 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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