Cleared Traditional

K973854 - ORION ANTERIOR CERVICAL PLATE SYSTEM

K973854 is an FDA 510(k) clearance for ORION ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Sofamor Danek USA,Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K973854 · Sofamor Danek USA,Inc. · Orthopedic device
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Mar 1998
Decision
164d
Days
Class 2
Risk

K973854 is an FDA 510(k) clearance for the ORION ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on March 16, 1998 after a review of 164 days - an extended review cycle.

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. 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 Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K973854

510(k) Number K973854 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 03, 1997
Decision Date March 16, 1998
Days to Decision 164 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
42d slower than avg
Panel avg: 122d · This submission: 164d
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 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K973854.
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
K983899 · United States Surgical, A Division of Tyco Healthc · Dec 1998
BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM
K974885 · Blackstone Medical, Inc. · Jun 1998
UNIVERSITY PLATE ANTERIOR SYSTEM
K980228 · Acromed Corp. · Apr 1998
AESCULAP ABC CERVICAL PLATING SYSTEM
K974706 · Aesculap, Inc. · Mar 1998
KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS
K974757 · Acromed Corp. · Mar 1998
SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM
K974525 · Synthes Spine · Mar 1998