FDA 510(k) Applications Submitted by Erin Combs

FDA 510(k) Number Submission Date Device Name Applicant
K200854 03/31/2020 DePuy PINNACLE Dual Mobility Liner DePuy Ireland UC
K201348 05/21/2020 DePuy 3D Additive TriFlange Acetabular Cup DePuy International, Ltd
K211657 05/28/2021 EMPHASYS Femoral Stems DePuy Ireland UC
K202194 08/05/2020 ATTUNE« Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUMÖ 3DP Technology DePuy Ireland UC
K202248 08/10/2020 Attune Revision Sleeve LPS Femoral Adaptors DePuy Ireland UC
K212746 08/30/2021 ATTUNE Revision Cones Depuy Ireland UC
K202769 09/21/2020 VELYSÖ Robotic-Assisted Solution DePuy Ireland UC
K203167 10/23/2020 DePuy Corail AMT Hip Prosthesis DePuy Orthopaedics Inc.
K203532 12/02/2020 BI-MENTUMÖ ALTRX« Dual Mobility Liner Depuy Ireland UC
K213781 12/03/2021 ATTUNE« Porous Fixed Bearing Tibial Base with AFFIXIUMÖ 3DP DePuy Ireland UC
K193398 12/06/2019 Summit DuoFix HA Coating DePuy Orthopaedics, Inc.
K213839 12/09/2021 DePuy Corail AMT Hip Prosthesis DePuy Orthopaedics Inc.
K193540 12/20/2019 TRUMATCH Personalized Solutions DePuy Orthopaedics, Inc.
K193549 12/20/2019 SIGMA High Performance (HP) Partial Knee System DePuy Ireland UC


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