Cleared Traditional

K162884 - SpineGuard DSG Zavation Screw System

K162884 is an FDA 510(k) clearance for SpineGuard DSG Zavation Screw System, manufactured by Spineguard S.A.. The device is a Class 2 Neurology device with product code HBG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K162884 · Spineguard S.A. · Neurology device
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Jan 2017
Decision
90d
Days
Class 2
Risk

K162884 is an FDA 510(k) clearance for the SpineGuard DSG Zavation Screw System. Classified as Drills, Burrs, Trephines & Accessories (manual) (product code HBG), Class II - Special Controls.

Submitted by Spineguard S.A. (Vincennes, FR). The FDA issued a Cleared decision on January 12, 2017 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4300 - 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 Spineguard S.A. devices

FDA 510(k) Submission Details - K162884

510(k) Number K162884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2016
Decision Date January 12, 2017
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBG Device Classification - Class 2, Special Controls

Product Code HBG Drills, Burrs, Trephines & Accessories (manual)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4300
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 - HBG Drills, Burrs, Trephines & Accessories (manual)

Devices cleared under the same product code (HBG) and FDA review panel - the closest regulatory comparables to K162884.
LEGACY
K252696 · Phasor Health, LLC · Nov 2025
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K153587 · Synthes USA Products, LLC · Jan 2017
FRAMELOCK
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K915546 · Pudenz-Schulte Medical Research Corp. · Dec 1991
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K904283 · Pudenz-Schulte Medical Research Corp. · Oct 1990
NEUROSURGICAL DRILLS: STILLE, HUDSON
K892531 · Zinnanti Surgical Instruments, Inc. · May 1989