Cleared Traditional

K003549 - CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS

K003549 is an FDA 510(k) clearance for CODMAN CRANIOSORB ABSORBABLE FIXATION S..., manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K003549 · Codman & Shurtleff, Inc. · Dental device
Download Printable Device Report (PDF)
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Feb 2001
Decision
90d
Days
Class 2
Risk

K003549 is an FDA 510(k) clearance for the CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on February 15, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Codman & Shurtleff, Inc. devices

FDA 510(k) Submission Details - K003549

510(k) Number K003549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2000
Decision Date February 15, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 238
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K003549.
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
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LORENZ RESORBABLE DISTRACTOR SYSTEM
K002083 · Walter Lorenz Surgical, Inc. · Feb 2001
THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY
K002426 · Bioplate, Inc. · Jan 2001
THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE
K994060 · Bioplate, Inc. · Jan 2001