AXIS 5.5 Lumbar Pedicle Screw System

FDA 510(k) K180301 · Axis Orthopaedics

Substantially Equivalent

510(k) numberK180301

Submission

Device name
AXIS 5.5 Lumbar Pedicle Screw System
Applicant
Axis Orthopaedics
Soldotna, AK, US
Received
February 2, 2018
Decision date
April 10, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NKB – Thoracolumbosacral Pedicle Screw System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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Questions and answers

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

AXIS 5.5 Lumbar Pedicle Screw System (K180301) received a 510(k) decision of Substantially Equivalent on April 10, 2018, 67 days after the submission was received.

What is the product code of K180301?

The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.