Cleared Traditional

K837776 - AOR X-RAY ALIGMENT PAD

K837776 is an FDA 510(k) clearance for AOR X-RAY ALIGMENT PAD, manufactured by Zimmer, Inc.. The device is a Class 1 Radiology device with product code IXJ cleared through the Traditional 510(k) pathway after a 229-day FDA review.

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

FDA 510(k) Submission Details - K837776

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 107d · This submission: 229d
Pathway characteristics
Predicate-based equivalence.

IXJ Device Classification - Class 1, General Controls

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.