Cleared Special

K200863 - Tiger® Occipital-Cervical-Thoracic Spinal Fixation System

K200863 is an FDA 510(k) clearance for Tiger Occipital-Cervical-Thoracic Spina..., manufactured by Corelink, LLC. The device is a Class 2 Orthopedic device with product code NKG cleared through the Special 510(k) pathway after a 27-day FDA review.

K200863 · Corelink, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
27d
Days
Class 2
Risk

K200863 is an FDA 510(k) clearance for the Tiger® Occipital-Cervical-Thoracic Spinal Fixation System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Corelink, LLC (St. Louis, US). The FDA issued a Cleared decision on April 28, 2020 after a review of 27 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.

FDA 510(k) Submission Details - K200863

510(k) Number K200863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2020
Decision Date April 28, 2020
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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

Empirical Testing Corp
Nathan Wright

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 118
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K200863.
Centurion POCT System
K201481 · Orthofix, Inc. · Jun 2020
Invictus™ CT Spinal Fixation System
K200936 · Alphatec Spine, Inc. · May 2020
PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
K200571 · Spineart · May 2020
Solstice CCI
K200896 · Life Spine, Inc. · Apr 2020
VERTICALE® Cervical System
K192013 · Silony Medical GmbH · Apr 2020
SYMPHONY™ OCT System
K192646 · Medos International SARL · Apr 2020
K200863 · Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
Download PDF FDA Summary Corelink, LLC