Cleared Traditional

K895587 - CROSS MEDICAL PRODUCT PEDICLE AWL (FDA 510(k) Clearance)

Class I Orthopedic device.

K895587 · Cross Medical Products, Inc. · Orthopedic device
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Jan 1990
Decision
111d
Days
Class 1
Risk

K895587 is an FDA 510(k) clearance for the CROSS MEDICAL PRODUCT PEDICLE AWL. Classified as Awl (product code HWJ), Class I - General Controls.

Submitted by Cross Medical Products, Inc. (Martinez, US). The FDA issued a Cleared decision on January 4, 1990 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 Cross Medical Products, Inc. devices

Submission Details

510(k) Number K895587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1989
Decision Date January 04, 1990
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HWJ Awl
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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.