Cleared Special

K183383 - ANAX OCT Spinal System

K183383 is the FDA 510(k) clearance for ANAX OCT Spinal System by U&I Corporation. It is a Class 2 Orthopedic device (product code NKG) cleared through the Special 510(k) pathway after a 6-day FDA review.

K183383 · U&I Corporation · Orthopedic device
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Dec 2018
Decision
6d
Days
Class 2
Risk

K183383 is an FDA 510(k) clearance for the ANAX™ OCT Spinal System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by U&I Corporation (Uijeongbu-Si, KR). The FDA issued a Cleared decision on December 12, 2018 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3075 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all U&I Corporation devices

Submission Details

510(k) Number K183383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2018
Decision Date December 12, 2018
Days to Decision 6 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 122d · This submission: 6d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NKG Posterior Cervical Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3075
Definition Posterior Cervical Screw Systems Are Intended For Use In Fusion Procedures Of The Cervical Spine And/or Craniocervical Junction And/or Cervicothoracic Junction For: 1) Spinal Fractures And Dislocations; 2) Deformities; 3) Instabilities; 4) Failed Previous Fusions; 5) Tumors; 6) Inflammatory Disorders; 7) Spinal Degeneration, 8) Facet Degeneration With Instability; And 9) Reconstruction Following Decompression To Treat Radiculopathy And/or Myelopathy. These Systems Are Also Intended To Stabilize The Spine In The Absence Of Fusion For A Limited Time Period In Patients With Tumors Involving The Cervical Spine In Whom Life Expectancy Is Of Insufficient Duration To Permit Achievement Of Fusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NKG Posterior Cervical Screw System

All 96
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K183383.
M.U.S.T. MINI Posterior Cervical Screws System
K190631 · Medacta International S.A. · Apr 2019
Perla® Posterior Cervico-Thoracic Fixation System
K190071 · Spineart · Feb 2019
M.U.S.T. Mini Extension
K182837 · Medacta International S.A. · Jan 2019
YUKON OCT Spinal System
K182182 · K2m · Nov 2018
Saxxony™ Posterior Cervical Thoracic System
K182508 · Nexxt Spine, LLC · Nov 2018
EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
K181603 · K2m, Inc. · Oct 2018