Cleared Traditional

COHORT(TM) ANTERIOR PLATE SYSTEM (APS) (K950011) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950011 · Cohort Medical Products Group, Inc. · Orthopedic device
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Nov 1995
Decision
307d
Days
Class 2
Risk

K950011 is an FDA 510(k) clearance for the COHORT(TM) ANTERIOR PLATE SYSTEM (APS). Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Cohort Medical Products Group, Inc. (Hayward, US). The FDA issued a Cleared decision on November 6, 1995 after a review of 307 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 Cohort Medical Products Group, Inc. devices

Submission Details

510(k) Number K950011 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 03, 1995
Decision Date November 06, 1995
Days to Decision 307 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 122d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 239
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K950011.
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
K964416 · Synthes (Usa) · Mar 1997
DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM
K962486 · Depuy, Inc. · Dec 1996
CODMAN ANTERIOR CERVICAL PLATE SYSTEM
K953730 · Johnson & Johnson Professionals, Inc. · Nov 1995
AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION
K953720 · Aesculap, Inc. · Nov 1995
SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K945700 · Synthes (Usa) · Jul 1995
CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM
K934756 · Codman & Shurtleff, Inc. · Nov 1994