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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K211474
Device Name Kleiner KG2 System
Applicant
BAAT Medical Products B.V.
F. Hazemeijerstraat 800
Bldg. A04
Hengelo,  NL 7555 RJ
Applicant Contact Kelsey van Abbema
Correspondent
BAAT Medical Products B.V.
F. Hazemeijerstraat 800
Bldg. A04
Hengelo,  NL 7555 RJ
Correspondent Contact Martjin Heikens
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/12/2021
Decision Date 09/14/2021
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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