Medical Device Manufacturer · US , San Diego , CA

Medacta International

39 submissions · 39 cleared · Since 2011
39
Total
39
Cleared
0
Denied

Medacta International — FDA 510(k) Submissions

Medacta International has submitted 39 FDA 510(k) premarket notifications since 2011, of which 39 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented, Thoracolumbosacral Pedicle Screw System, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Intervertebral Fusion Device With Bone Graft, Lumbar . Use the specialty filter in the sidebar to narrow results.

39 devices
1–12 of 39
MectaLIF Anterior Stand-Alone
K160605 · OVD Intervertebral Fusion... · Orthopedic
Jul 2016 141d
MasterLoc Stem
K160289 · LZO Prosthesis, Hip,... · Orthopedic
May 2016 107d
M.U.S.T. Pedicle Screw System
K153664 · NKB Thoracolumbosacral... · Orthopedic
Jan 2016 29d
MasterLoc Stem
K151531 · LZO Prosthesis, Hip,... · Orthopedic
Oct 2015 144d
Mecta-C TiPEEK
K142744 · ODP Intervertebral Fusion... · Orthopedic
May 2015 225d
Mpact Double Mobility System
K143453 · LPH Prosthesis, Hip,... · Orthopedic
Mar 2015 89d
GMK EXTENSION
K142069 · JWH Prosthesis, Knee,... · Orthopedic
Dec 2014 125d
M.U.S.T PEDICLE SCREW SYSTEM
K141988 · NKB Thoracolumbosacral... · Orthopedic
Aug 2014 28d
M.U.S.T. EXTENSION
K141044 · NKB Thoracolumbosacral... · Orthopedic
Aug 2014 117d
GMK SPHERE EXTENSION
K140826 · JWH Prosthesis, Knee,... · Orthopedic
Jul 2014 105d
META-C CERVICAL PLATE
K140361 · KWQ Appliance, Fixation,... · Orthopedic
Jun 2014 120d
MYSPINE PEDICLE SCREW PLACEMENT GUIDES
K132788 · MNI Orthosis, Spinal Pedicle... · Orthopedic
May 2014 259d

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