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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Growing Rod System
510(k) Number K251961
Device Name SDS Growing Rod
Applicant
BAAT Medical Products B.V.
F. Hazemeijerstraat 800
Bldg. A04
Hengelo,  NL 7555 RJ
Applicant Contact Jasper Springer
Correspondent
BAAT Medical Products B.V.
F. Hazemeijerstraat 800
Bldg. A04
Hengelo,  NL 7555 RJ
Correspondent Contact Jasper Springer
Regulation Number888.3070
Classification Product Code
PGM  
Date Received06/26/2025
Decision Date 01/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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