Cleared Traditional

K170939 - Supplemental Instrument Trays

K170939 is an FDA 510(k) clearance for Supplemental Instrument Trays, manufactured by Nuvasive Specialized Orthopedics, Incorporated. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K170939 · Nuvasive Specialized Orthopedics, Incorporated · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
131d
Days
Class 2
Risk

K170939 is an FDA 510(k) clearance for the Supplemental Instrument Trays. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Nuvasive Specialized Orthopedics, Incorporated (Aliso Viejo, US). The FDA issued a Cleared decision on August 8, 2017 after a review of 131 days - within the typical 510(k) review window.

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 Nuvasive Specialized Orthopedics, Incorporated devices

FDA 510(k) Submission Details - K170939

510(k) Number K170939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2017
Decision Date August 08, 2017
Days to Decision 131 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 129d · This submission: 131d
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 173
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K170939.
SterilContainer with PrimeLine Pro Lid
K172850 · Aesculap, Inc. · Nov 2017
iTotal Family Reusable Instrument Tray
K170226 · Conformis, Inc. · Oct 2017
Endoscope Sterilization Tray
K170640 · Intuitive Surgical, Inc. · Sep 2017
Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
K163598 · Advanced Sterilization Products · Jul 2017
SterilContainer S System
K162815 · Aesculap, Inc. · Jul 2017
Medtronic Transportation/Sterilization Cassettes
K163279 · Medtronic Sofamor Danek USA, Inc. · Feb 2017