510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161680Substantially Equivalent

MEDICON Spinal Spreading Systems

Medicon, E.G., Tuttlingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161680 is the FDA 510(k) clearance record for MEDICON Spinal Spreading Systems, a class II device, cleared for Medicon EG on under FDA product code GZT (Retractor, Self-Retaining, For Neurosurgery). FDA records list 17 510(k) clearances for Medicon EG, from to . As of , FDA records show no recalls naming K161680.

Clearance record

Decision date
Received
(280 days to decision)
Product code
GZT Retractor, Self-Retaining, For Neurosurgery
Regulation
21 CFR 882.4800
Device class
Class II
Review panel
Neurology
Applicant
Medicon EG Gansacker 15, Tuttlingen, DE
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 October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZT, 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 20261
October 20260