Cleared Traditional

K870084 - RD 140 SURGICAL BENDER

K870084 is an FDA 510(k) clearance for RD 140 SURGICAL BENDER, manufactured by Terray Manufacturing, Inc.. The device is a Class 1 Orthopedic device with product code HXW cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K870084 · Terray Manufacturing, Inc. · Orthopedic device
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Jan 1987
Decision
20d
Days
Class 1
Risk

K870084 is an FDA 510(k) clearance for the RD 140 SURGICAL BENDER. Classified as Bender (product code HXW), Class I - General Controls.

Submitted by Terray Manufacturing, Inc. (Ontario K7s 1l8, CA). The FDA issued a Cleared decision on January 28, 1987 after a review of 20 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 Terray Manufacturing, Inc. devices

FDA 510(k) Submission Details - K870084

510(k) Number K870084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1987
Decision Date January 28, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

HXW Device Classification - Class 1, General Controls

Product Code HXW Bender
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.