Cleared Traditional

K895587 - CROSS MEDICAL PRODUCT PEDICLE AWL

K895587 is an FDA 510(k) clearance for CROSS MEDICAL PRODUCT PEDICLE AWL, manufactured by Cross Medical Products, Inc.. The device is a Class 1 Orthopedic device with product code HWJ cleared through the Traditional 510(k) pathway after a 111-day FDA review.

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

FDA 510(k) Submission Details - K895587

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.

HWJ Device Classification - Class 1, General Controls

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.