Cleared Traditional

K143579 - NuVasive Sterilization Trays

K143579 is an FDA 510(k) clearance for NuVasive Sterilization Trays, manufactured by Nu Vasive, Incorporated. The device is a Class 2 General Hospital device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K143579

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.

KCT Device Classification - Class 2, Special Controls

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 181
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
InterActive Complete Surgical Tray
K142519 · Implant Direct Sybron Manufacturing, LLC · Apr 2015