Cleared Traditional

TENET TIBIAL FRACTURE SUPPORT (K964102) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K964102 · Tenet Medical Engineering · General & Plastic Surgery device
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Dec 1996
Decision
55d
Days
Class 1
Risk

K964102 is an FDA 510(k) clearance for the TENET TIBIAL FRACTURE SUPPORT. Classified as Chair, Surgical, Ac-powered (product code GBB), Class I - General Controls.

Submitted by Tenet Medical Engineering (Calgary Alberta, CA). The FDA issued a Cleared decision on December 5, 1996 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - the FDA general and plastic surgery device 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.

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Submission Details

510(k) Number K964102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1996
Decision Date December 05, 1996
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBB Chair, Surgical, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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.