510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K090272Substantially Equivalent

Spetzler Scalp Retractor Clamps (Various Styles and Sizes)

Medtronic, Inc., Mcgaw Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090272 is the FDA 510(k) clearance record for SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES), a class II device, cleared for Cardinal Health, Inc. on under FDA product code GZT (Retractor, Self-Retaining, For Neurosurgery). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K090272.

Clearance record

Decision date
Received
(42 days to decision)
Product code
GZT Retractor, Self-Retaining, For Neurosurgery
Regulation
21 CFR 882.4800
Device class
Class II
Review panel
Neurology
Applicant
Cardinal Health, Inc. 1430 Waukegan Rd.- Mpkb-2b, Mcgaw Park IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZT

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