510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K182436Substantially Equivalent

POWEREASE System

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

K182436 is the FDA 510(k) clearance record for POWEREASE System, a class II device, cleared for Medtronic Sofamor Danek USA, Inc. on under FDA product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)). FDA records list 182 510(k) clearances for Medtronic Sofamor Danek USA, Inc., from to . As of , FDA records show no recalls naming K182436.

Clearance record

Decision date
Received
(27 days to decision)
Product code
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation
21 CFR 882.4310
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Pl., Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBE

Trailing 12 months
2 clearances under product code HBE in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HBE, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260