Cleared Traditional

K893928 - LEVTECH SMALL BONE PLATE

K893928 is an FDA 510(k) clearance for LEVTECH SMALL BONE PLATE, manufactured by Buckman Co., Inc.. The device is a Class 2 Orthopedic device with product code KTW cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K893928 · Buckman Co., Inc. · Orthopedic device
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Nov 1989
Decision
156d
Days
Class 2
Risk

K893928 is an FDA 510(k) clearance for the LEVTECH SMALL BONE PLATE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on November 3, 1989 after a review of 156 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Buckman Co., Inc. devices

FDA 510(k) Submission Details - K893928

510(k) Number K893928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1989
Decision Date November 03, 1989
Days to Decision 156 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
34d slower than avg
Panel avg: 122d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTW Device Classification - Class 2, Special Controls

Product Code KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component

All 30
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K893928.
TORUS EXTERNAL FIXATION SYSTEM
K925635 · Zimmer, Inc. · Jun 1993
ANGLED BLADE PLATE
K914546 · Synthes (Usa) · Nov 1991
HANSEN-STREET TYPE INTRAMEDULLARY NAIL
K905348 · O'Tec Corp. · Dec 1990
WARSAW ORTHOPEDIC I BONE PLATE
K870727 · Warsaw Orthopedic, Inc. · Mar 1987
ACROMED ADS BONE NAIL
K862552 · Buckman Co., Inc. · Sep 1986
ORTHOPEDIC FIXATION DEVICES
K821566 · Howmedica Corp. · Jun 1982