510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103136Substantially Equivalent

Surgicase Cmf, Surgicase Connect, Surgicase Guide

Materialise N.V., Leuven, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103136 is the FDA 510(k) clearance record for SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE, a class II device, cleared for Materialise NV on under FDA product code JEY (Plate, Bone). FDA records list 61 510(k) clearances for Materialise NV, from to . As of , FDA records show one recall naming K103136.

Clearance record

Decision date
Received
(144 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Materialise NV 15 Technologielaan, Leuven, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JEY

Trailing 12 months
5 clearances under product code JEY 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 JEY, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260