Cleared Special

K013877 - CODMAN SLIM-LOC SYSTEM

K013877 is an FDA 510(k) clearance for CODMAN SLIM-LOC SYSTEM, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 26-day FDA review.

K013877 · Codman & Shurtleff, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
26d
Days
Class 2
Risk

K013877 is an FDA 510(k) clearance for the CODMAN SLIM-LOC SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on December 19, 2001 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K013877

510(k) Number K013877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2001
Decision Date December 19, 2001
Days to Decision 26 days
Submission Type Special
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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 663
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K013877.
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
ANTERIOR CERVICAL PLATE SYSTEM
K013439 · Scien'Tx USA, Inc. · Jan 2002
FRONTIER ANTERIOR SCOLIOSIS SYSTEM
K012916 · Depuy Acromed, Inc. · Nov 2001
C3 ANTERIOR CERVICAL PLATE SYSTEM
K012881 · Spine Vision, Inc. · Nov 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · Aesculap, Inc. · Nov 2001
K013877 · CODMAN SLIM-LOC SYSTEM
Download PDF FDA Summary Codman & Shurtleff, I…