Cleared Traditional

K910874 - THORACIC ANTERIOR SPINAL FIXATION PLATE

K910874 is an FDA 510(k) clearance for THORACIC ANTERIOR SPINAL FIXATION PLATE, manufactured by Terray Manufacturing, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K910874 · Terray Manufacturing, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
339d
Days
Class 2
Risk

K910874 is an FDA 510(k) clearance for the THORACIC ANTERIOR SPINAL FIXATION PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Terray Manufacturing, Inc. (Ontario K7s 1l8, CA). The FDA issued a Cleared decision on February 3, 1992 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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. Elevated predicate reliance profile. 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 - K910874

510(k) Number K910874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1991
Decision Date February 03, 1992
Days to Decision 339 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 122d · This submission: 339d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 639
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K910874.
STERILE DYNA LOK ANTERIOR PLATING SYSTEM
K923446 · Sofamor Danek Mfg., Inc. · Dec 1992
ANTERIOR CERVICAL PLATE SYSTEM
K922087 · Sofamor Danek Mfg., Inc. · Nov 1992
AESCULAP TITANIUM BONE PLATES
K913730 · Aesculap, Inc. · Mar 1992
MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS)
K901507 · Kirschner Medical Corp. · Jan 1992
SIMMONS PLATING SYSTEM
K910681 · Smith & Nephew Richards, Inc. · Oct 1991
CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.)
K904446 · Acromed Corp. · Sep 1991