Cleared Traditional

K834515 - FIXATION STAPLE KIT - DLIDE HAMMER (FDA 510(k) Clearance)

Class I Orthopedic device.

K834515 · Stryker Corp. · Orthopedic device
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Apr 1984
Decision
124d
Days
Class 1
Risk

K834515 is an FDA 510(k) clearance for the FIXATION STAPLE KIT - DLIDE HAMMER. Classified as Staple Driver (product code HXJ), Class I - General Controls.

Submitted by Stryker Corp. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 124 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 Stryker Corp. devices

Submission Details

510(k) Number K834515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date April 23, 1984
Days to Decision 124 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 122d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HXJ Staple Driver
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.