Cleared Traditional

K143540 - Stryker MIS Attachments and Cutting Accessories

K143540 is an FDA 510(k) clearance for Stryker MIS Attachments and Cutting Acc..., manufactured by Stryker Corporation. The device is a Class 2 Neurology device with product code HBE cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K143540 · Stryker Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
137d
Days
Class 2
Risk

K143540 is an FDA 510(k) clearance for the Stryker MIS Attachments and Cutting Accessories. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on May 1, 2015 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Corporation devices

FDA 510(k) Submission Details - K143540

510(k) Number K143540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2014
Decision Date May 01, 2015
Days to Decision 137 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 148d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBE Device Classification - Class 2, Special Controls

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
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 Neurology devices follow this clearance model.

Regulatory Peers - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 42
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K143540.
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K113476 · The Anspach Effort, Inc. · Dec 2011