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FDA 510(k) Application Details - K192449
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K192449
Device Name
Cement, Bone, Vertebroplasty
Applicant
Joline GmbH & Co. KG
Neue RottenBurger Strasse 50
Hechingen 72379 DE
Other 510(k) Applications for this Company
Contact
Peter Kohlbecher
Other 510(k) Applications for this Contact
Regulation Number
888.3027
More FDA Info for this Regulation Number
Classification Product Code
NDN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/06/2019
Decision Date
05/27/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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