Cleared Traditional

K890164 - HUDSON BRACE W/BURRS

K890164 is an FDA 510(k) clearance for HUDSON BRACE W/BURRS, manufactured by Dhason Brothers, Inc.. The device is a Class 1 Orthopedic device with product code LXH cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K890164 · Dhason Brothers, Inc. · Orthopedic device
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Feb 1989
Decision
35d
Days
Class 1
Risk

K890164 is an FDA 510(k) clearance for the HUDSON BRACE W/BURRS. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Dhason Brothers, Inc. (Hyattsville, US). The FDA issued a Cleared decision on February 13, 1989 after a review of 35 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dhason Brothers, Inc. devices

FDA 510(k) Submission Details - K890164

510(k) Number K890164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1989
Decision Date February 13, 1989
Days to Decision 35 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

LXH Device Classification - Class 1, General Controls

Product Code LXH Orthopedic Manual Surgical Instrument
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 - LXH Orthopedic Manual Surgical Instrument

All 30
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K890164.
DRIVER/EXTRACTOR
K903257 · Onyx Medical Corp. · Jul 1990
T-HANDLE HEX WRENCH
K903270 · Onyx Medical Corp. · Jul 1990
COHN TARGETEER
K891903 · Orthopedic Systems, Inc. · May 1989
TENSIOMETER
K883694 · W.L. Gore & Associates, Inc. · Nov 1988
SPINAL DISTRACTORS, SPANNERS
K882069 · Karlin Technology, Inc. · Jun 1988
MICRODISCECTOMY CURRETTES
K882077 · Karlin Technology, Inc. · Jun 1988