Cleared Traditional

K143579 - NuVasive Sterilization Trays

K143579 is the FDA 510(k) clearance for NuVasive Sterilization Trays by Nu Vasive, Incorporated. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K143579 · Nu Vasive, Incorporated · General Hospital
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Aug 2015
Decision
253d
Days
Class 2
Risk

K143579 is an FDA 510(k) clearance for the NuVasive Sterilization Trays. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on August 28, 2015 after a review of 253 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Nu Vasive, Incorporated devices

Submission Details

510(k) Number K143579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date August 28, 2015
Days to Decision 253 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 129d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 145
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K143579.
Medtronic Transportation/Sterilization Cassettes
K152241 · Medtronic Sofamor Danek USA, Inc. · Jan 2016
Endoscope Sterilization Tray
K151450 · Intuitive Surgical, Inc. · Jan 2016
SterilContainer S
K151242 · Aesculap, Inc. · Oct 2015
SterilContainer S
K143729 · Aesculap, Inc. · Aug 2015
SterilContainer S System
K142970 · Aesculap, Inc. · Jul 2015
Endoscope Sterilization Tray
K142937 · Intuitive Surgical, Inc. · Feb 2015