Cleared Traditional

K161032 - neon3™ universal OCT spinal stabilization

K161032 is an FDA 510(k) clearance for neon3 universal OCT spinal stabilization, manufactured by Ulrich GmbH & Co. KG. The device is a Class 2 Orthopedic device with product code NKG cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K161032 · Ulrich GmbH & Co. KG · Orthopedic device
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Dec 2016
Decision
253d
Days
Class 2
Risk

K161032 is an FDA 510(k) clearance for the neon3™ universal OCT spinal stabilization. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Ulrich GmbH & Co. KG (Ulm, DE). The FDA issued a Cleared decision on December 22, 2016 after a review of 253 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ulrich GmbH & Co. KG devices

FDA 510(k) Submission Details - K161032

510(k) Number K161032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2016
Decision Date December 22, 2016
Days to Decision 253 days
Submission Type Traditional
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
131d slower than avg
Panel avg: 122d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKG Device Classification - Class 2, Special Controls

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 Consultant

Ulrich Medical USA
Hans Stover

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NKG Posterior Cervical Screw System

All 117
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K161032.
Z-LINKPC System
K162575 · Zavation, LLC · Mar 2017
Proficient™ Posterior Cervical Spine System
K162639 · Spine Wave, Inc. · Feb 2017
Poseidon OCT Spinal Fixation System
K161637 · Medyssey USA, Inc. · Jan 2017
Reform® POCT System
K162300 · Precision Spine, Inc. · Nov 2016
CastleLoc-S Posterior Cervical Fixation System
K162136 · L & K Biomed Co., Ltd. · Nov 2016
QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
K161591 · Globus Medical, Inc. · Sep 2016