Cleared Traditional

K923776 - BENDEREV DRILL GUIDE (FDA 510(k) Clearance)

Class I Orthopedic device.

K923776 · Neimark Labs, Inc. · Orthopedic device
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Nov 1992
Decision
101d
Days
Class 1
Risk

K923776 is an FDA 510(k) clearance for the BENDEREV DRILL GUIDE. Classified as Brace, Drill (product code HXY), Class I - General Controls.

Submitted by Neimark Labs, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on November 6, 1992 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Neimark Labs, Inc. devices

Submission Details

510(k) Number K923776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date November 06, 1992
Days to Decision 101 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HXY Brace, Drill
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.