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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Proximal Femoral, Implant
510(k) Number K262184
Device Name GANNET®
Applicant
BAAT Medical Products B.V.
F. Hazemeijerstraat 800
Bldg. A04
Hengelo,  NL 7555RJ
Applicant Contact Jasper Springer
Correspondent
BAAT Medical Products B.V.
F. Hazemeijerstraat 800
Bldg. A04
Hengelo,  NL 7555RJ
Correspondent Contact Jasper Springer
Regulation Number888.3030
Classification Product Code
JDO  
Subsequent Product Codes
HSB   KTT  
Date Received06/29/2026
Decision Date 10/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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