Cleared Traditional

K831982 - BRADFORD SPINAL FRACTURE FIXATION SYS

K831982 is an FDA 510(k) clearance for BRADFORD SPINAL FRACTURE FIXATION SYS, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K831982 · Depuy, Inc. · Orthopedic device
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Sep 1983
Decision
92d
Days
Class 2
Risk

K831982 is an FDA 510(k) clearance for the BRADFORD SPINAL FRACTURE FIXATION SYS. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1983 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K831982

510(k) Number K831982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1983
Decision Date September 20, 1983
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 616
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K831982.
CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.)
K904446 · Acromed Corp. · Sep 1991
ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION
K873826 · Acromed Corp. · Nov 1988
OEC/REZAIAN SPINAL FIXATOR
K841189 · Orthopedic Equipment Co., Inc. · May 1984
ANTERIOR KYPHOSIS DISTRACTION DEVICE
K802222 · Zimmer, Inc. · Oct 1980
SYNTHES CERVICAL VERTABRAE PLATES
K792352 · DePuy Synthes · Dec 1979
D.T.T. LOCK SCREW INSERTER
K790941 · Depuy, Inc. · May 1979