Cleared Traditional

K923776 - BENDEREV DRILL GUIDE

K923776 is an FDA 510(k) clearance for BENDEREV DRILL GUIDE, manufactured by Neimark Labs, Inc.. The device is a Class 1 Orthopedic device with product code HXY cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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

FDA 510(k) Submission Details - K923776

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.

HXY Device Classification - Class 1, General Controls

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.

Regulatory Peers - HXY Brace, Drill

Devices cleared under the same product code (HXY) and FDA review panel - the closest regulatory comparables to K923776.
MITEK DRILL GUIDE
K892904 · Mitek Surgical Products, Inc. · Sep 1989
BONE SUTURE FIXATION DEVICE
K880264 · Orthopedic Systems, Inc. · Mar 1988
HASTING FINGER FIXATOR INSTRUMENTS
K880046 · Buckman Co., Inc. · Feb 1988
ANDREWS REMOTE CHUCK DRILL
K831043 · Orthopedic Systems, Inc. · Apr 1983
CEMENT EXTRACTOR DRILL
K770204 · Depuy, Inc. · Feb 1977