Cleared Traditional

K901144 - LEVTECH BONE SCREW

K901144 is an FDA 510(k) clearance for LEVTECH BONE SCREW, manufactured by Levtech, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K901144 · Levtech, Inc. · Orthopedic device
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Oct 1990
Decision
212d
Days
Class 2
Risk

K901144 is an FDA 510(k) clearance for the LEVTECH BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Levtech, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 10, 1990 after a review of 212 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Levtech, Inc. devices

FDA 510(k) Submission Details - K901144

510(k) Number K901144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date October 10, 1990
Days to Decision 212 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 122d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 976
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K901144.
CANCELLOUS SCREW
K905358 · O'Tec Corp. · Jan 1991
ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW
K903810 · Ace Medical Co. · Oct 1990
ACE CANNULATED CORTICAL BONE SCREW
K903811 · Ace Medical Co. · Oct 1990
CANCELLOUS SCREW
K903253 · Onyx Medical Corp. · Aug 1990
U.S. TYPE CRUCIATE SLOT BONE SCREW
K903254 · Onyx Medical Corp. · Aug 1990
CORTICAL BONE SCREW (EUROPEAN STYLE)
K903255 · Onyx Medical Corp. · Aug 1990