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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Cerclage Wires;K-wires;Steinmann Pins

FDA 510(k) source

510(k) number
K262126
Applicant
MK Medical GmbH
Decision date
Oct 22, 2026
Date received
Jun 24, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
HTY
Device type
Pin, Fixation, Smooth
Device class
Class II
Regulation
21 CFR 888.3040
Advisory committee
Orthopedic
Statement or summary
Summary
Third party
N
Location
Emmingen-Liptingen, DE