Cleared Traditional

K120271 - ARTISAN SPACE MAINTENANCE SYSTEM

K120271 is the FDA 510(k) clearance for ARTISAN SPACE MAINTENANCE SYSTEM by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K120271 · Medtronic Sofamor Danek USA, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
May 2012
Decision
121d
Days
Class 2
Risk

K120271 is an FDA 510(k) clearance for the ARTISAN SPACE MAINTENANCE SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on May 30, 2012 after a review of 121 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K120271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2012
Decision Date May 30, 2012
Days to Decision 121 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
6d faster than avg
Panel avg: 127d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 157
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