510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K120271Substantially Equivalent

Artisan Space Maintenance System

Medtronic Sofamor Danek USA Inc, Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120271 is the FDA 510(k) clearance record for ARTISAN SPACE MAINTENANCE SYSTEM, a class II device, cleared for Medtronic Sofamor Danek USA, Inc. on under FDA product code JEY (Plate, Bone). FDA records list 182 510(k) clearances for Medtronic Sofamor Danek USA, Inc., from to . As of , FDA records show no recalls naming K120271.

Clearance record

Decision date
Received
(121 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Pl., Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JEY

Trailing 12 months
4 clearances under product code JEY in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JEY, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260
November 20260