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FDA 510(k) Application Details - K221855
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K221855
Device Name
Plate, Bone
Applicant
Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
Freiburg D-79111 DE
Other 510(k) Applications for this Company
Contact
Amelia Kesti
Other 510(k) Applications for this Contact
Regulation Number
872.4760
More FDA Info for this Regulation Number
Classification Product Code
JEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/27/2022
Decision Date
11/09/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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