Cleared Traditional

K012184 - BLACKSTONE III ANTERIOR CERVICAL PLATIN...

K012184 is the FDA 510(k) clearance for BLACKSTONE III ANTERIOR CERVICAL PLATIN... by Blackstone Medical, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K012184 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
202d
Days
Class 2
Risk

K012184 is an FDA 510(k) clearance for the BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on January 30, 2002 after a review of 202 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 Blackstone Medical, Inc. devices

Submission Details

510(k) Number K012184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2001
Decision Date January 30, 2002
Days to Decision 202 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 122d · This submission: 202d
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 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K012184.
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K020650 · Howmedica Osteonics Corp. · Mar 2002
SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM
K013979 · Spinal Concepts, Inc. · Feb 2002
ENDIUS CERVICAL PLATE SYSTEM
K014107 · Endius, Inc. · Feb 2002
PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K013665 · Medtronic Sofamor Danek, Inc. · Jan 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
K013558 · Blackstone Medical, Inc. · Jan 2002
CODMAN SLIM-LOC SYSTEM
K013877 · Codman & Shurtleff, Inc. · Dec 2001