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FDA 510(k) Applications Submitted by Heike Gustke
FDA 510(k) Number
Submission Date
Device Name
Applicant
K170418
02/13/2017
Stryker SonicPin System
Stryker Trauma Gmbh
K180436
02/20/2018
T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
Stryker Trauma GmbH
K220492
02/22/2022
COPAL exchange G hip spacer
Heraeus Medical GmbH
K191271
05/13/2019
T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
Stryker Trauma Gmbh
K132102
07/08/2013
BECE CAD ZIRKON HT+
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
K151879
07/09/2015
VariAx 2 One-Third Tubular Plating System
STRYKER GMBH
K172774
09/14/2017
T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
Stryker Trauma Gmbh
K123929
12/20/2012
BEGOPAL+
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
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