510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043602Substantially Equivalent

Quadrant Retractor System

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

K043602 is the FDA 510(k) clearance record for QUADRANT RETRACTOR SYSTEM, a class I device, cleared for Medtronic Sofamor Danek on under FDA product code GAD (Retractor). FDA records list 253 510(k) clearances for Medtronic Sofamor Danek, from to . As of , FDA records show no recalls naming K043602.

Clearance record

Decision date
Received
(56 days to decision)
Product code
GAD Retractor
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Medtronic Sofamor Danek 1800 Pyramid Pl., Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAD

Trailing 12 months

FDA records hold no clearances under product code GAD in the trailing twelve months.

FDA records show no clearances under product code GAD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260