Cleared Traditional

K901521 - OSTEOTOMES OF VARIOUS TYPES

K901521 is an FDA 510(k) clearance for OSTEOTOMES OF VARIOUS TYPES, manufactured by Mumtaz I. Malik. The device is a Class 1 Physical Medicine device with product code LXH cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K901521 · Mumtaz I. Malik · Physical Medicine device
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Sep 1990
Decision
179d
Days
Class 1
Risk

K901521 is an FDA 510(k) clearance for the OSTEOTOMES OF VARIOUS TYPES. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Mumtaz I. Malik (Elizabethtown, US). The FDA issued a Cleared decision on September 28, 1990 after a review of 179 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 888.4540 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Mumtaz I. Malik devices

FDA 510(k) Submission Details - K901521

510(k) Number K901521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1990
Decision Date September 28, 1990
Days to Decision 179 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 115d · This submission: 179d
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 29
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K901521.
STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH
K941605 · Stryker Corp. · Aug 1994
SOFAMOR ORTHOPAEDIC INSTRUMENTS
K933242 · Danek Medical, Inc. · Jan 1994
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
T-HANDLE HEX WRENCH
K903270 · Onyx Medical Corp. · Jul 1990