Cleared Traditional

K253943 - Tiger 2 System

K253943 is an FDA 510(k) clearance for Tiger 2 System, manufactured by Zavation Medical Products, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K253943 · Zavation Medical Products, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
226d
Days
Class 2
Risk

K253943 is an FDA 510(k) clearance for the Tiger 2 System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Zavation Medical Products, LLC (Flowood, US). The FDA issued a Cleared decision on July 24, 2026 after a review of 226 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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.

FDA 510(k) Submission Details - K253943

510(k) Number K253943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2025
Decision Date July 24, 2026
Days to Decision 226 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
104d slower than avg
Panel avg: 122d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To 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 - NKB Thoracolumbosacral Pedicle Screw System

All 914
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K253943.
FRAXION Spinal Fixation System
K262091 · Ortler Global Tibbi Gerecler Anonim Sirketi · Sep 2026
RIVA® Posterior Fixation System with NanoACTIV Surface Technology
K262193 · Xenix Medical · Sep 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K262828 · S.M.A.I.O · Sep 2026
QUATTRO Spinal system (Open Configuration)
K260362 · MANTIZ Co., Ltd. · Jul 2026
Invictus® Small Stature Spinal Fixation System
K261284 · Alphatec Spine, Inc. · Jul 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K253802 · S.M.A.I.O · Jul 2026
K253943 · Tiger 2 System
Download PDF FDA Summary Zavation Medical Prod…