Medacta International S.A. - FDA 510(k) Cleared Devices
165
Total
165
Cleared
0
Denied
158 devices
Cleared
May 30, 2019
MasterLoc Extension
Orthopedic
30d
Cleared
May 28, 2019
MectaLock PEEK Suture Anchor
Orthopedic
90d
Cleared
Apr 10, 2019
M.U.S.T. MINI Posterior Cervical Screws System
Orthopedic
29d
Cleared
Mar 21, 2019
MPACT Extension
Orthopedic
90d
Cleared
Mar 15, 2019
MectaLIF Anterior Stand Alone Extension
Orthopedic
94d
Cleared
Jan 30, 2019
MOTO Partial Knee System
Orthopedic
90d
Cleared
Jan 22, 2019
M.U.S.T. Mini Extension
Orthopedic
105d
Cleared
Dec 10, 2018
Glenoid Polyaxial Non-locking Screws
Orthopedic
154d
Cleared
Dec 04, 2018
MectaLIF Posterior Extension
Orthopedic
133d
Cleared
Nov 28, 2018
SMS Femoral Stem
Orthopedic
154d
Cleared
Oct 22, 2018
Quadra P
Orthopedic
164d
Cleared
Aug 23, 2018
GMK Sphere - Kinematic Alignment
Orthopedic
245d
Cleared
Aug 23, 2018
GMK Sphere CR Tibial Inserts
Orthopedic
63d
Cleared
Apr 19, 2018
MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments
Orthopedic
161d
Cleared
Apr 05, 2018
Medacta Shoulder System Short Humeral Diaphysis
Orthopedic
83d
Cleared
Mar 27, 2018
Mpact® 3D Metal™ Implants and Augments 3D Metal™
Orthopedic
270d
Cleared
Mar 14, 2018
AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
Orthopedic
90d
Cleared
Dec 13, 2017
Medacta Shoulder System: Threaded Glenoid Baseplate
Orthopedic
247d
Cleared
Dec 07, 2017
MasterLoc Stem: Lateralized Plus
Orthopedic
57d
Cleared
Nov 29, 2017
M-Vizion Femoral Revision System
Orthopedic
267d
Cleared
Nov 01, 2017
GMK Hinge, GMK Revision
Orthopedic
90d
Cleared
Oct 23, 2017
M-ARS ACL: Anatomic Ribbon Surgery System
Orthopedic
143d
Cleared
Oct 20, 2017
MyKnee PPS-Pin Positioners
Orthopedic
281d
Cleared
Oct 05, 2017
Medacta Shoulder System
Orthopedic
232d
Cleared
Sep 18, 2017
Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
Orthopedic
21d
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