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FDA 510(k) Applications Submitted by KATHY HARRIS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190344
02/14/2019
DePuy Corail AMT Hip Prosthesis
DePuy (Ireland)
K070554
02/27/2007
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC.
K071016
04/10/2007
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
DEPUY ORTHOPAEDICS, INC.
K071059
04/16/2007
DEPUY SPA POROUS COATED PROXIMAL SLEEVE
DEPUY ORTHOPAEDICS, INC.
K191779
07/02/2019
Attune Revision LPS Inserts
Depuy (Ireland)
K182301
08/24/2018
PFC SIGMA Knee System
DePuy Orthopaedics, Inc.
K212683
08/24/2021
GLOBAL ICON Stemless Shoulder System
DePuy (Ireland)
K192919
10/15/2019
Pinnacle Duofix HA Acetabular Cup Prosthesis
DePuy Orthopaedics, Inc.
K192946
10/18/2019
DePuy Corail AMT Hip Prosthesis
DePuy Orthopaedics, Inc.
K193057
11/01/2019
ATTUNE All-Polyethylene Tibia
DePuy Ireland UC
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