Cleared Traditional

K002184 - COD COMPRESSION OSTEOTOMY DEVICE

K002184 is an FDA 510(k) clearance for COD COMPRESSION OSTEOTOMY DEVICE, manufactured by Walter Abendschein, M.D.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K002184 · Walter Abendschein, M.D. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
128d
Days
Class 2
Risk

K002184 is an FDA 510(k) clearance for the COD COMPRESSION OSTEOTOMY DEVICE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Walter Abendschein, M.D. (Chevy Chase, US). The FDA issued a Cleared decision on November 24, 2000 after a review of 128 days - within the typical 510(k) review window.

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 Walter Abendschein, M.D. devices

FDA 510(k) Submission Details - K002184

510(k) Number K002184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2000
Decision Date November 24, 2000
Days to Decision 128 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 1204
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K002184.
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K002710 · Synthes (Usa) · Sep 2000