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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

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.

Regulatory Peers - HXJ Staple Driver

Devices cleared under the same product code (HXJ) and FDA review panel - the closest regulatory comparables to K834515.
IN-TAC BONE ANCHOR SYSTEM
K964953 · Influence, Inc. · Feb 1997
UROTAC BONE ANCHOR INSERTER
K962372 · Influence, Inc. · Aug 1996
ELECTRIC WIRE DRIVER, MODEL 2640E
K930205 · Micro Surgical Instruments Corp. · Aug 1993
OSTEOTOMY BONE STAPLE
K830255 · Techmedica, Inc. · Mar 1983
STAPLE INSERTER-EXTRACTOR FOR ARTHROS
K830456 · Instrument Makar, Inc. · Mar 1983
K834515 · FIXATION STAPLE KIT - DLIDE HAMMER
Download PDF Stryker Corp.