Cleared Traditional

K837776 - AOR X-RAY ALIGMENT PAD (FDA 510(k) Clearance)

Class I Radiology device.

K837776 · Zimmer, Inc. · Radiology device
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Aug 1983
Decision
229d
Days
Class 1
Risk

K837776 is an FDA 510(k) clearance for the AOR X-RAY ALIGMENT PAD. Classified as Grid, Radiographic (product code IXJ), Class I - General Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 18, 1983 after a review of 229 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1910 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K837776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 01, 1983
Decision Date August 18, 1983
Days to Decision 229 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 107d · This submission: 229d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXJ Grid, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1910
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.