510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K901393Substantially Equivalent

Mainz Head Fixation by Perneczky

Zeppelin GmbH, West Germany, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901393 is the FDA 510(k) clearance record for MAINZ HEAD FIXATION BY PERNECZKY, a class II device, cleared for Zeppelin GmbH on under FDA product code HBL (Holder, Head, Neurosurgical (Skull Clamp)). FDA records list 2 510(k) clearances for Zeppelin GmbH, from to . As of , FDA records show no recalls naming K901393.

Clearance record

Decision date
Received
(162 days to decision)
Product code
HBL Holder, Head, Neurosurgical (Skull Clamp)
Regulation
21 CFR 882.4460
Device class
Class II
Review panel
Neurology
Applicant
Zeppelin GmbH Gistlstrabe 99, West Germany, DE
Third party review
No

Clearances, product code HBL

Trailing 12 months
1 clearance under product code HBL 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 HBL, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260