Cleared Traditional

K903270 - T-HANDLE HEX WRENCH

K903270 is an FDA 510(k) clearance for T-HANDLE HEX WRENCH, manufactured by Onyx Medical Corp.. The device is a Class 1 Orthopedic device with product code LXH cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K903270 · Onyx Medical Corp. · Orthopedic device
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Jul 1990
Decision
6d
Days
Class 1
Risk

K903270 is an FDA 510(k) clearance for the T-HANDLE HEX WRENCH. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Onyx Medical Corp. (Memphis, US). The FDA issued a Cleared decision on July 30, 1990 after a review of 6 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 Onyx Medical Corp. devices

FDA 510(k) Submission Details - K903270

510(k) Number K903270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1990
Decision Date July 30, 1990
Days to Decision 6 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 122d · This submission: 6d
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 22
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K903270.
CALMPS: BONE, MASTIN, LEWIN, BRAND
K930028 · Thomasville Medical Assoc. · Feb 1993
ADJUSTABLE ANGLE GUIDE
K903247 · Onyx Medical Corp. · Jul 1990
DRIVER/EXTRACTOR
K903257 · Onyx Medical Corp. · Jul 1990
COHN TARGETEER
K891903 · Orthopedic Systems, Inc. · May 1989
TENSIOMETER
K883694 · W.L. Gore & Associates, Inc. · Nov 1988
PATELLAR TENDON GRAFT GUIDE
K880413 · Concept, Inc. · Mar 1988