Cleared Traditional

K882871 - CASF DRILL GUIDE DG 170 (FDA 510(k) Clearance)

Class I Orthopedic device.

K882871 · Terray Manufacturing, Inc. · Orthopedic device
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Sep 1988
Decision
74d
Days
Class 1
Risk

K882871 is an FDA 510(k) clearance for the CASF DRILL GUIDE DG 170. Classified as Accessories, Fixation, Spinal Intervertebral Body (product code LYQ), Class I - General Controls.

Submitted by Terray Manufacturing, Inc. (Ontario K7s 1l8, CA). The FDA issued a Cleared decision on September 23, 1988 after a review of 74 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

Submission Details

510(k) Number K882871 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 11, 1988
Decision Date September 23, 1988
Days to Decision 74 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYQ Accessories, Fixation, Spinal Intervertebral Body
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.