Cleared Traditional

K150570 - ANAX OCT Spinal System

K150570 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 Traditional 510(k) pathway after a 89-day FDA review.

K150570 · U&I Corporation · Orthopedic device
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Jun 2015
Decision
89d
Days
Class 2
Risk

K150570 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, Gyeonggi-Do, KR). The FDA issued a Cleared decision on June 3, 2015 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all U&I Corporation devices

Submission Details

510(k) Number K150570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2015
Decision Date June 03, 2015
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 97
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K150570.
OASYS(r) System
K151755 · Stryker Corporation · Jul 2015
Virage OCT Spinal Fixation System
K151031 · Zimmer Spine, Inc. · Jun 2015
ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
K150552 · Globus Medical, Inc. · Jun 2015
Centurion POCT System
K150822 · Orthofix, Inc. · May 2015
OASYS System
K150539 · Stryker Corporation · May 2015
VERTEX Reconstruction System
K143471 · Medtronic Sofamor Danek USA, Inc. · Feb 2015