Cleared Traditional

K841189 - OEC/REZAIAN SPINAL FIXATOR

K841189 is an FDA 510(k) clearance for OEC/REZAIAN SPINAL FIXATOR, manufactured by Orthopedic Equipment Co., Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K841189 · Orthopedic Equipment Co., Inc. · Orthopedic device
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May 1984
Decision
57d
Days
Class 2
Risk

K841189 is an FDA 510(k) clearance for the OEC/REZAIAN SPINAL FIXATOR. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Orthopedic Equipment Co., Inc. (Walker, US). The FDA issued a Cleared decision on May 16, 1984 after a review of 57 days - a notably fast clearance cycle.

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: 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 Orthopedic Equipment Co., Inc. devices

FDA 510(k) Submission Details - K841189

510(k) Number K841189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1984
Decision Date May 16, 1984
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K841189.
SIMMONS PLATING SYSTEM
K910681 · Smith & Nephew Richards, Inc. · Oct 1991
CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.)
K904446 · Acromed Corp. · Sep 1991
ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION
K873826 · Acromed Corp. · Nov 1988
BRADFORD SPINAL FRACTURE FIXATION SYS
K831982 · Depuy, Inc. · Sep 1983
ANTERIOR KYPHOSIS DISTRACTION DEVICE
K802222 · Zimmer, Inc. · Oct 1980
D.T.T. LOCK SCREW INSERTER
K790941 · Depuy, Inc. · May 1979