Medacta International S.A. - FDA 510(k) Cleared Devices
165
Total
165
Cleared
0
Denied
158 devices
Cleared
Oct 29, 2023
NextAR™ TSA Platform
Orthopedic
90d
Cleared
Oct 18, 2023
MectaLIF Anterior Lag Extension
Orthopedic
93d
Cleared
Sep 20, 2023
Mpact Extension
Orthopedic
260d
Cleared
Jul 21, 2023
NextAR™ Spine Platform
Orthopedic
218d
Cleared
Jul 21, 2023
MySpine Unilateral Guides
Orthopedic
59d
Cleared
Jun 09, 2023
MyKnee UNI-ST
Orthopedic
58d
Cleared
May 30, 2023
MyPAO Guides
Orthopedic
446d
Cleared
Apr 17, 2023
SnugFit All-Suture Anchor extension
Orthopedic
48d
Cleared
Feb 24, 2023
MectaLock TI Triple Loaded Suture Anchor
Orthopedic
85d
Cleared
Jan 20, 2023
GMK Sphere & GMK SpheriKA Cementless
Orthopedic
56d
Cleared
Jan 17, 2023
FairFix QT Adjustable Button
Orthopedic
29d
Cleared
Nov 23, 2022
Glenoid Reconstruction System
Orthopedic
392d
Cleared
Oct 24, 2022
MectaLIF Anterior Extension
Orthopedic
150d
Cleared
Aug 23, 2022
GMK 3D Metal Tibial Tray
Orthopedic
57d
Cleared
Aug 16, 2022
FairFix Adjustable Button System
Orthopedic
26d
Cleared
Jul 22, 2022
DM Converter - TiN coated
Orthopedic
396d
Cleared
Jun 08, 2022
FairFix AM Adjustable Button FairFix PSP Adjustable Button
Orthopedic
26d
Cleared
May 24, 2022
M-Vizion Monobloc
Orthopedic
301d
Cleared
May 24, 2022
MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
Orthopedic
57d
Cleared
May 04, 2022
MyKnee R Pin Positioners
Orthopedic
55d
Cleared
Apr 26, 2022
M.U.S.T. MINI Posterior Cervical Screws System Extension
Orthopedic
57d
Cleared
Apr 12, 2022
Amis K Long
Orthopedic
57d
Cleared
Mar 10, 2022
NextAR™ TKA Platform My Knee PPS
Orthopedic
100d
Cleared
Feb 03, 2022
MectaScrew Extension
Orthopedic
448d
Cleared
Dec 20, 2021
Mpact® 3D Metal Implants - DMLS Technology
Orthopedic
472d
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