Cleared Traditional

K883784 - TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE (FDA 510(k) Clearance)

Class I Orthopedic device.

K883784 · Warsaw Orthopedic, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 122d · This submission: 212d
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.