Cleared Traditional

Supplemental Instrument Trays (K170939) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170939 · Nuvasive Specialized Orthopedics, Incorporated · General Hospital
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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

Submission Details

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.

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 140
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K170939.
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Medtronic Transportation/Sterilization Cassettes
K163279 · Medtronic Sofamor Danek USA, Inc. · Feb 2017
Sterilization Tray
K160912 · STERIS Corporation · Oct 2016