Cleared Traditional

K834515 - FIXATION STAPLE KIT - DLIDE HAMMER

K834515 is an FDA 510(k) clearance for FIXATION STAPLE KIT - DLIDE HAMMER, manufactured by Stryker Corp.. The device is a Class 1 Orthopedic device with product code HXJ cleared through the Traditional 510(k) pathway after a 124-day FDA review.

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

FDA 510(k) Submission Details - K834515

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 122d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

HXJ Device Classification - Class 1, General Controls

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.