Cleared Traditional

K962372 - UROTAC BONE ANCHOR INSERTER (FDA 510(k) Clearance)

Class I Orthopedic device.

K962372 · Influence, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 1996
Decision
61d
Days
Class 1
Risk

K962372 is an FDA 510(k) clearance for the UROTAC BONE ANCHOR INSERTER. Classified as Staple Driver (product code HXJ), Class I - General Controls.

Submitted by Influence, Inc. (San Francisco, US). The FDA issued a Cleared decision on August 19, 1996 after a review of 61 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Influence, Inc. devices

Submission Details

510(k) Number K962372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1996
Decision Date August 19, 1996
Days to Decision 61 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 122d · This submission: 61d
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.