Cleared Traditional

K883784 - TSRH ANTERIOR SPINAL SCREWS

K883784 is an FDA 510(k) clearance for TSRH ANTERIOR SPINAL SCREWS, manufactured by Warsaw Orthopedic, Inc.. The device is a Class 1 Orthopedic device with product code LYQ cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K883784 · Warsaw Orthopedic, Inc. · Orthopedic device
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Apr 1989
Decision
212d
Days
Class 1
Risk

K883784 is an FDA 510(k) clearance for the TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE. Classified as Accessories, Fixation, Spinal Intervertebral Body (product code LYQ), Class I - General Controls.

Submitted by Warsaw Orthopedic, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 6, 1989 after a review of 212 days - an extended review 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: 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.

View all Warsaw Orthopedic, Inc. devices

FDA 510(k) Submission Details - K883784

510(k) Number K883784 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 06, 1988
Decision Date April 06, 1989
Days to Decision 212 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
90d slower than avg
Panel avg: 122d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

LYQ Device Classification - Class 1, General Controls

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.