Cleared Traditional

K870085 - ANTERIOR SPINAL FIXATION PLATE

K870085 is an FDA 510(k) clearance for ANTERIOR SPINAL FIXATION PLATE, manufactured by Terray Manufacturing, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K870085 · Terray Manufacturing, Inc. · Orthopedic device
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Jun 1987
Decision
173d
Days
Class 2
Risk

K870085 is an FDA 510(k) clearance for the ANTERIOR SPINAL FIXATION PLATE. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Terray Manufacturing, Inc. (Ontario K7s 1l8, CA). The FDA issued a Cleared decision on June 30, 1987 after a review of 173 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Terray Manufacturing, Inc. devices

FDA 510(k) Submission Details - K870085

510(k) Number K870085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1987
Decision Date June 30, 1987
Days to Decision 173 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 122d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 398
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K870085.
ACROMED CROSS ROD CONNECTOR
K874882 · Acromed Corp. · Feb 1988
TSRH H/M TORQUE LIMITING WRENCH
K880214 · Warsaw Orthopedic, Inc. · Feb 1988
TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD
K880215 · Warsaw Orthopedic, Inc. · Feb 1988
WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM
K870830 · Warsaw Orthopedic, Inc. · May 1987
MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM
K854770 · Advanced Biosearch Assn. · Feb 1986
KIRSCHNER SPINAL PRODUCT SYSTEM
K854524 · Kirschner Medical Corp. · Dec 1985