Cleared Traditional

K152920 - Savannah-T Pedicle Screw System

K152920 is the FDA 510(k) clearance for Savannah-T Pedicle Screw System by Amendia, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K152920 · Amendia, Inc. · Orthopedic device
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Jul 2016
Decision
280d
Days
Class 2
Risk

K152920 is an FDA 510(k) clearance for the Savannah-T® Pedicle Screw System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Amendia, Inc. (Marietta, US). The FDA issued a Cleared decision on July 8, 2016 after a review of 280 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.

View all Amendia, Inc. devices

Submission Details

510(k) Number K152920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2015
Decision Date July 08, 2016
Days to Decision 280 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
158d slower than avg
Panel avg: 122d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 650
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K152920.
SeaSpine® NewPort™ Spinal System
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PathLoc-L MIS Spinal System
K161766 · L & K Biomed Co., Ltd. · Aug 2016
Threshold™ Pedicular Fixation System
K161694 · Spineology, Inc. · Jul 2016
Expedium Spine System, VIPER and VIPER 2 Systems
K160904 · Medos International SARL · Jul 2016
Arsenal Spinal Fixation System
K161363 · Alphatec Spine, Inc. · Jun 2016
NuVasive® Reline® System
K160989 · Nu Vasive, Incorporated · Jun 2016