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FDA 510(k) Application Details - K191433
Device Classification Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
More FDA Info for this Device
510(K) Number
K191433
Device Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant
Implantcast GmbH
Lueneburger Schanze 26
Buxtehude 21614 DE
Other 510(k) Applications for this Company
Contact
Juliane Hoppner
Other 510(k) Applications for this Contact
Regulation Number
888.3690
More FDA Info for this Regulation Number
Classification Product Code
HSD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/29/2019
Decision Date
11/12/2020
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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