Medacta Usa Inc

FDA Filings

This page includes the latest FDA filings for Medacta Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006639916
• FEI Number: 3006639916
• Name: Medacta USA, Inc.
• Owner & Operator: Medacta International SA
• Contact Address: Strada Regina ; Castel San Pietro CH-TI Ticino 6874 CH
• Official Correspondent:
  • Stefano Baj
  • 41-91-6966060-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3973 Delp St. ; Memphis, TN 38118 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K192967 | PHX Medacta USA, Inc. [Medacta International SA]	Medacta Shoulder System	2020-03-25
PMN K192967 | KWT Medacta USA, Inc. [Medacta International SA]	Medacta Shoulder System	2020-03-25
PMN K192967 | KWS Medacta USA, Inc. [Medacta International SA]	Medacta Shoulder System	2020-03-25
PMN K192967 | HSD Medacta USA, Inc. [Medacta International SA]	Medacta Shoulder System	2020-03-25
PMN K200075 | JWH Medacta USA, Inc. [Medacta International SA]	3DMetal Diaphyseal Femoral Cones	2020-03-13
PMN K041623 | FRG Medacta USA, Inc. [Medacta International SA]	Aesculap Sterilization Pans	2020-03-10
PMN K200048 | MAX Medacta USA, Inc. [Medacta International SA]	MectaLIF Anterior Simple	2020-03-09
PMN K192906 | OVE Medacta USA, Inc. [Medacta International SA]	Mecta-C Stand Alone	2020-03-04
MDM Medacta USA, Inc. [Medacta International SA]	ORTHOPEDIC DISPOSABLE SURGICAL NEEDLE	2020-02-19
PMN K200130 | NKG Medacta USA, Inc. [Medacta International SA]	M.U.S.T. MINI Posterior Cervical Screws System	2020-02-11
PMN K200130 | KWP Medacta USA, Inc. [Medacta International SA]	M.U.S.T. MINI Posterior Cervical Screws System	2020-02-11
PMN K193165 | MBI Medacta USA, Inc. [Medacta International SA]	MectaFix CL Fixation Button with Continuous Loop	2020-02-10
PMN K193165 | JDR Medacta USA, Inc. [Medacta International SA]	MectaFix CL Fixation Button with Continuous Loop	2020-02-10
PMN K193165 | HWC Medacta USA, Inc. [Medacta International SA]	MectaFix CL Fixation Button with Continuous Loop	2020-02-10
PMN K193461 | MBI Medacta USA, Inc. [Medacta International SA]	MectaLock All-Suture Anchors	2020-02-06
PMN K191677 | MBI Medacta USA, Inc. [Medacta International SA]	MectaTap TI Suture Anchor	2020-01-29
PMN K193365 | NKB Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Pedicle Screw System	2020-01-28
PMN K193365 | KWQ Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Pedicle Screw System	2020-01-28
PMN K193365 | KWP Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Pedicle Screw System	2020-01-28
PMN K193433 | LZO Medacta USA, Inc. [Medacta International SA]	AMIStem-C	2020-01-09
PMN K193433 | JDI Medacta USA, Inc. [Medacta International SA]	AMIStem-C	2020-01-09
PMN K192827 | MEH Medacta USA, Inc. [Medacta International SA]	Quadra-P	2020-01-06
PMN K192827 | LZY Medacta USA, Inc. [Medacta International SA]	Quadra-P	2020-01-06
PMN K192827 | LZO Medacta USA, Inc. [Medacta International SA]	Quadra-P	2020-01-06
PMN K192827 | LPH Medacta USA, Inc. [Medacta International SA]	Quadra-P	2020-01-06
PMN K192827 | KWY Medacta USA, Inc. [Medacta International SA]	Quadra-P	2020-01-06
PMN K192827 | JDI Medacta USA, Inc. [Medacta International SA]	Quadra-P	2020-01-06
PMN K190738 | PHX Medacta USA, Inc. [Medacta International SA]	MyShoulder? Placement Guides	2019-12-13
PMN K190738 | MBF Medacta USA, Inc. [Medacta International SA]	MyShoulder? Placement Guides	2019-12-13
PMN K190738 | KWS Medacta USA, Inc. [Medacta International SA]	MyShoulder? Placement Guides	2019-12-13
PMN K190738 | HSD Medacta USA, Inc. [Medacta International SA]	MyShoulder? Placement Guides	2019-12-13
PMN K193083 | OUR Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System	2019-12-03
PMN K193083 | HWC Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System	2019-12-03
PMN K193083 | HTN Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System	2019-12-03
PMN K192126 | LZO Medacta USA, Inc. [Medacta International SA]	AMIStem-P Short Neck	2019-11-22
PMN K192352 | LZO Medacta USA, Inc. [Medacta International SA]	MiniMAX	2019-10-03
PMN K191300 | MBI Medacta USA, Inc. [Medacta International SA]	MectaLock Ti Suture Anchor	2019-09-13
PMN K181086 | MBI Medacta USA, Inc. [Medacta International SA]	Cortical Fixation Systems	2019-07-24
GEA Medacta USA, Inc. [Medacta International SA]	Cannula System	2019-07-24
GAD Medacta USA, Inc. [Medacta International SA]	Mectaflip	2019-07-24
GAA Medacta USA, Inc. [Medacta International SA]	Access kit	2019-07-24
EMF Medacta USA, Inc. [Medacta International SA]	MectaQTH	2019-07-24
GFF Medacta USA, Inc. [Medacta International SA]	KOMET SURGICAL BUR GENERAL & PLASTIC SURGERY	2019-07-11
PMN K190892 | MBI Medacta USA, Inc. [Medacta International SA]	MectaScrew PEEK?	2019-06-05
PMN K191145 | MEH Medacta USA, Inc. [Medacta International SA]	MasterLoc? Stem Extension	2019-05-31
PMN K191145 | LZY Medacta USA, Inc. [Medacta International SA]	MasterLoc? Stem Extension	2019-05-31
PMN K191145 | LZO Medacta USA, Inc. [Medacta International SA]	MasterLoc? Stem Extension	2019-05-31
PMN K191145 | LPH Medacta USA, Inc. [Medacta International SA]	MasterLoc? Stem Extension	2019-05-31
PMN K191145 | KWY Medacta USA, Inc. [Medacta International SA]	MasterLoc? Stem Extension	2019-05-31
PMN K190474 | MBI Medacta USA, Inc. [Medacta International SA]	MectaLock PEEK? Suture Anchor	2019-05-29
PMN K190631 | NKG Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Mini Posterior Cervical Screw System	2019-04-10
PMN K190631 | KWP Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Mini Posterior Cervical Screw System	2019-04-10
PMN K183582 | LPH Medacta USA, Inc. [Medacta International SA]	MPACT Extension - Face Changing Liners	2019-03-21
PMN K183426 | OVD Medacta USA, Inc. [Medacta International SA]	MectaLIF Anterior Extension	2019-03-18
PMN K183029 | HSX Medacta USA, Inc. [Medacta International SA]	MOTO Lateral	2019-01-30
PMN K182837 | NKG Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Mini Extension	2019-01-22
PMN K182837 | KWP Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Mini Extension	2019-01-22
PMN K181826 | PHX Medacta USA, Inc. [Medacta International SA]	Glenoid Polyaxial Non-Locking Screw	2018-12-10
PMN K181826 | MBF Medacta USA, Inc. [Medacta International SA]	Glenoid Polyaxial Non-Locking Screw	2018-12-10
PMN K181826 | KWS Medacta USA, Inc. [Medacta International SA]	Glenoid Polyaxial Non-Locking Screw	2018-12-10
PMN K181826 | HSD Medacta USA, Inc. [Medacta International SA]	Glenoid Polyaxial Non-Locking Screw	2018-12-10
NBH Medacta USA, Inc. [Medacta International SA]	Manual Arthroscopic Instruments	2018-12-05
PMN K181970 | MAX Medacta USA, Inc. [Medacta International SA]	MectaLIF Posterior Extension	2018-12-04
PMN K181693 | MEH Medacta USA, Inc. [Medacta International SA]	SMS Cementless Stem	2018-11-30
PMN K181693 | LZY Medacta USA, Inc. [Medacta International SA]	SMS Cementless Stem	2018-11-30
PMN K181693 | LZO Medacta USA, Inc. [Medacta International SA]	SMS Cementless Stem	2018-11-30
PMN K181693 | LPH Medacta USA, Inc. [Medacta International SA]	SMS Cementless Stem	2018-11-30
PMN K181693 | KWY Medacta USA, Inc. [Medacta International SA]	SMS Cementless Stem	2018-11-30
PMN K181254 | MEH Medacta USA, Inc. [Medacta International SA]	Quadra-P	2018-10-24
PMN K181254 | LZY Medacta USA, Inc. [Medacta International SA]	Quadra-P	2018-10-24
PMN K181254 | LZO Medacta USA, Inc. [Medacta International SA]	Quadra-P	2018-10-24
PMN K181254 | LPH Medacta USA, Inc. [Medacta International SA]	Quadra-P	2018-10-24
PMN K181254 | KWY Medacta USA, Inc. [Medacta International SA]	Quadra-P	2018-10-24
PMN K173890 | JWH Medacta USA, Inc. [Medacta International SA]	GMK Sphere - Kinematic Alignment	2018-08-24
PMN K181635 | JWH Medacta USA, Inc. [Medacta International SA]	GMK Sphere Tibial Inserts	2018-08-23
PMN K173472 | PQC Medacta USA, Inc. [Medacta International SA]	MySpine Pedicle Screw Placement Guides ? MC and Drill Pilot Instruments	2018-04-19
PMN K180089 | PHX Medacta USA, Inc. [Medacta International SA]	Medacta Shoulder System Short Humeral Diaphysis	2018-04-05
PMN K180089 | MBF Medacta USA, Inc. [Medacta International SA]	Medacta Shoulder System Short Humeral Diaphysis	2018-04-05
PMN K180089 | KWS Medacta USA, Inc. [Medacta International SA]	Medacta Shoulder System Short Humeral Diaphysis	2018-04-05
PMN K171966 | LZO Medacta USA, Inc. [Medacta International SA]	Mpact 3D Metal Implants and Augments 3D Metal	2018-03-28
PMN K171966 | LPH Medacta USA, Inc. [Medacta International SA]	Mpact 3D Metal Implants and Augments 3D Metal	2018-03-28
PMN K173794 | MEH Medacta USA, Inc. [Medacta International SA]	AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared	2018-03-15
PMN K173794 | LZY Medacta USA, Inc. [Medacta International SA]	AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared	2018-03-15
PMN K173794 | LZO Medacta USA, Inc. [Medacta International SA]	AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared	2018-03-15
PMN K173794 | LPH Medacta USA, Inc. [Medacta International SA]	AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared	2018-03-15
PMN K173794 | KWY Medacta USA, Inc. [Medacta International SA]	AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared	2018-03-15
PMN K171058 | PHX Medacta USA, Inc. [Medacta International SA]	Medacta Shoulder System: Threaded Glenoid Baseplate	2017-12-13
PMN K173267 | MEH Medacta USA, Inc. [Medacta International SA]	MasterLoc? Stem: Lateralized Plus	2017-12-08
PMN K173267 | LZY Medacta USA, Inc. [Medacta International SA]	MasterLoc? Stem: Lateralized Plus	2017-12-08
PMN K173267 | LZO Medacta USA, Inc. [Medacta International SA]	MasterLoc? Stem: Lateralized Plus	2017-12-08
PMN K173267 | LPH Medacta USA, Inc. [Medacta International SA]	MasterLoc? Stem: Lateralized Plus	2017-12-08
PMN K173267 | KWY Medacta USA, Inc. [Medacta International SA]	MasterLoc? Stem: Lateralized Plus	2017-12-08
PMN K170690 | LZO Medacta USA, Inc. [Medacta International SA]	M-Vizion Femoral Revision System	2017-11-29
PMN K170690 | KWY Medacta USA, Inc. [Medacta International SA]	M-Vizion Femoral Revision System	2017-11-29
PMN K172347 | KRO Medacta USA, Inc. [Medacta International SA]	GMK Hinge, GMK Revision	2017-11-02
PMN K172347 | JWH Medacta USA, Inc. [Medacta International SA]	GMK Hinge, GMK Revision	2017-11-02
PMN K171640 | MBI Medacta USA, Inc. [Medacta International SA]	M-ARS ACL: Anatomic Ribbon Surgery System	2017-10-23
PMN K170106 | JWH Medacta USA, Inc. [Medacta International SA]	MyKnee PPS-Pin Positioners	2017-10-20
PMN K170452 | PHX Medacta USA, Inc. [Medacta International SA]	Medacta Shoulder System - Reverse	2017-10-09
PMN K170452 | MBF Medacta USA, Inc. [Medacta International SA]	Medacta Shoulder System - Reverse	2017-10-09
PMN K170452 | HSD Medacta USA, Inc. [Medacta International SA]	Medacta Shoulder System - Reverse	2017-10-09
PMN K172587 | ODP Medacta USA, Inc. [Medacta International SA]	Mecta-C with titanium markers	2017-09-18
PMN K172587 | ODP Medacta USA, Inc. [Medacta International SA]	Mecta-C TiPEEK with titanium markers	2017-09-18
PMN K170149 | JWH Medacta USA, Inc. [Medacta International SA]	3DMetal Tibial Cones	2017-08-21
PMN K170910 | KWS Medacta USA, Inc. [Medacta International SA]	Medacta Anatomic Shoulder Prosthesis	2017-08-16
PMN K170845 | MEH Medacta USA, Inc. [Medacta International SA]	MiniMAX	2017-08-08
PMN K170845 | LZY Medacta USA, Inc. [Medacta International SA]	MiniMAX	2017-08-08
PMN K170845 | LZO Medacta USA, Inc. [Medacta International SA]	MiniMAX	2017-08-08
PMN K170845 | KWY Medacta USA, Inc. [Medacta International SA]	MiniMAX	2017-08-08
PMN K171595 | OUR Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System	2017-08-02
PMN K171595 | HWC Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System	2017-08-02
PMN K171595 | HTN Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System	2017-08-02
PMN K171758 | NKB Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Combined Set Screws	2017-08-01
PMN K171758 | KWQ Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Combined Set Screws	2017-08-01
PMN K171758 | KWP Medacta USA, Inc. [Medacta International SA]	M.U.S.T. Combined Set Screws	2017-08-01
PMN K171369 | NKG Medacta USA, Inc. [Medacta International SA]	M.U.S.T. MINI Posterior Cervical Screws System	2017-08-01
PMN K171369 | KWP Medacta USA, Inc. [Medacta International SA]	M.U.S.T. MINI Posterior Cervical Screws System	2017-08-01
LXH Medacta USA, Inc. [Medacta International SA]	Manual Orthopedic Instruments	2008-02-11

Related Finance Registrations

NCAGE Code	6PZ49	MEDACTA USA, INC.
CAGE Code	6PZ49	MEDACTA USA, INC.
S.A.M. Registration	6PZ49 [14782020]	MEDACTA USA, INC.