510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163182Substantially Equivalent

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

Medtronic Powered Surgical Solutions, Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163182 is the FDA 510(k) clearance record for Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories, a class II device, cleared for Medtronic Powered Surgical Solutions on under FDA product code HBB (Motor, Drill, Pneumatic). FDA records list 9 510(k) clearances for Medtronic Powered Surgical Solutions, from to . As of , FDA records show no recalls naming K163182.

Clearance record

Decision date
Received
(129 days to decision)
Product code
HBB Motor, Drill, Pneumatic
Regulation
21 CFR 882.4370
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Powered Surgical Solutions 4620 N. Beach St., Fort Worth TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBB

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