FDA Registration
Active
🇨🇭 Switzerland
MEDACTA INTERNATIONAL SA
Reg #: 3005180920
·
FEI: 3005180920
·
Expires 2026
Products
106
Proprietary Names
283
Establishment Types
6
Classifications
106
Registration Details
- Registration Name
- MEDACTA INTERNATIONAL SA
- Registration Number
- 3005180920
- FEI Number
- 3005180920
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Strada Regina
- City
- Castel San Pietro Ticino
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K234048
Owner / Operator
- Firm Name
- Medacta International SA
- Operator Number
- 10024526
- Address
- Strada Regina
- City
- Castel San Pietro
- State
- Ticino
- Postal Code
- 6874
- Country
- CH
- Correspondent
- Stefano Baj
US Agent
- Business Name
- Medacta USA
- Contact Name
- Christopher Lussier
- Address
- 6386 Global Drive, Suite 101
- City
- Memphis
- State
- TN
- ZIP
- 38141
- Country
- US
- [email protected]
- Phone
- 901 2033470
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2023-01-16 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-02-14 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2024-02-14 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-02-14 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2017-10-23 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2017-04-17 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2017-03-06 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2024-06-13 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-06-13 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2021-07-23 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2026-02-04 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2023-09-21 |
| Orthopedic Augmented Reality | SBF | Class 2 | Neurology | No | 2026-01-12 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2021-03-02 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2021-03-02 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2021-03-02 |
| Table, Operating-Room, Mechanical | FWX | Class 1 | General, Plastic Surgery | No | 2008-02-11 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2020-03-04 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-07-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-11-05 |
| Evacuator, Vapor, Cement Monomer | JDY | Class 1 | Orthopedic | No | 2022-01-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2011-03-29 |
| Motor, Surgical Instrument, Pneumatic Powered | GET | Class 1 | General, Plastic Surgery | No | 2008-06-04 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Pedicle Screw Placement Guide | PQC | Class 2 | Orthopedic | No | 2018-04-19 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2017-04-03 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2017-04-03 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2017-04-03 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-06-11 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2010-03-30 |
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2023-02-10 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2010-03-30 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2008-02-11 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2017-08-02 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2017-08-02 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2021-06-10 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2019-03-18 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2025-06-12 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-05-28 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2017-09-18 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2023-01-05 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2021-10-13 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2018-05-08 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2017-06-09 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2025-06-20 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2021-10-13 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2009-01-22 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2009-01-22 |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | Class 1 | Orthopedic | No | 2023-01-05 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2023-01-21 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2021-03-02 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2020-02-10 |
| Punch, Femoral Neck | HWP | Class 1 | Orthopedic | No | 2023-01-05 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2020-02-19 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-12-26 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2022-03-10 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2014-10-27 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2025-06-11 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2020-10-05 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2024-05-04 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2025-06-12 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2023-01-16 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2014-09-12 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2014-09-12 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2025-06-12 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2019-07-11 |
| Shoulder Arthroplasty Implantation System | QHE | Class 2 | Orthopedic | No | 2025-02-03 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-01-05 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2023-01-05 |
| Cement Obturator | LZN | Class 2 | General, Plastic Surgery | No | 2023-02-21 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Prosthesis, Hip, Cement Restrictor | JDK | Class 2 | General, Plastic Surgery | No | 2022-11-23 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2023-01-05 |
| Sacroiliac Screw Placement Guide | QSR | Class 2 | Orthopedic | No | 2023-07-22 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2024-06-14 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2022-01-11 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2023-02-10 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2023-01-05 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2025-07-02 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-03-25 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2025-06-12 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2025-06-12 |
| Intraoperative Orthopedic Joint Assessment Aid | ONN | Class 2 | Neurology | No | 2011-01-28 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2025-04-16 |
| Probe | HXB | Class 1 | Orthopedic | No | 2023-01-16 |
| Posterior Cervical Screw Placement Guide | QSD | Class 2 | Orthopedic | No | 2023-12-08 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2018-12-05 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2020-04-20 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2020-04-20 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2010-03-30 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2025-08-22 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2025-08-04 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2025-06-12 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-06-12 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2022-02-17 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
Proprietary Names
Curette
Osteotome
M.U.S.T. Pedicle Screw System Extension
M-ARS ACL: Anatomic Ribbon Surgery System
GMK Sphere
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
MySpine WebPlanner & MyBalance
MSS Monobloc stem
SecureFix Meniscus Repair
Rasp
Mpact Extension
M.U.S.T. MINI Posterior Cervical Screws System
SnugFit All-Suture Anchor
NextAR Hip Platform
MectaLock All-Suture Anchors
Shoulder System - TiNbN Coating
AMIS Table
Mecta-C Stand Alone
MectaLIF 3D Metal
Mectacer Biolox Option Heads
X-Twist PEEK Suture Anchor
M.U.S.T Pedicle Screw System
Vacuum Pump
MSS - Humeral reverse liners extension
Quadra C
IMT Motorized broach
Gaston
Access kit
MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments
M.U.S.T. Pedicle Screw Extension and Long Tab Implants
MasterLoc
Cortical Fixation Systems
V-LOX PEEK CF SUTURE ANCHOR
MectaBone-P Injection System
Injector Instrumentation
Sterilization tray
MectaBone-G
GFS BTB
Knotless PEEK and PEEK CF Push-In Suture Anchor
Medacta Bone Screws
MITI TITANIUM SUTURE ANCHOR
Manual Orthopedic Instruments
FairFix QT Adjustable Button
AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
NextAR TKA Platform
MectaQTH
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
PowerSuture
MectaLIF Transforaminal TiPEEK
Glenoid Reconstruction System Full Wedge Baseplate
MyHip Planner & Verifier
MectaLIF Anterior Extension
Clamp
GMK Full PE Tibial Components
M-Vizion Femoral Revision System Extension
Surgical Instrument
Passer
MySpine Pedicle Screw Placement Guides
Reverse Shoulder
Mecta-C TiPEEK with titanium markers
Mecta-C with titanium markers
Total Hip Prosthesis System ¿ CoCr Line Extension
Titanium Interference Screw
ATLAS
Mpres Neck Preserving Stem
Rongeur
Titanium Interference Screws
MectaLIF
AMIStem H;
Quadra S and H Stems
Mectacem-X
Intradisk; K-Wire; Renova Spine Kyphoplasty Kirschner Guide
Mfinity Femoral System
Mpact DM Converter
MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
MectaLIF Anterior
AMIStem and Quadra - Line Extension
Mectacem-X (With Gentamicin)
MectaTap TI Suture Anchor
iMNS Medacta Navigation System
Mecta-C Stand Alone Extension
Humeral Eccentric Reverse Metaphysis
M.U.S.T. Pedicle Screw System - Extension
Spinal Instrument
GMK Sphere & GMK SpheriKA Cementless
MectaLIF Anterior Stand-Alone
Mecta-C Cervical Plate
DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
GMK Revision & Hinge Extension - TiNbN Coating
3DMetal Diaphyseal Femoral Cones
MiniMAX
MectaLIF Posterior Extension
Versafitcup CC Trio extension
MectaScrew Extension
PULLUP Adjustable Juxtacortical Fixation Device
GMK 3D Metal Tibial Tray Extension
MectaFix CL Fixation Button with Continuous Loop
3DMetal Tibial Cones
GMK-SPHERE Spherika Femurs and Tibial Trays Plus
Punch
ORTHOPEDIC DISPOSABLE SURGICAL NEEDLE
Coated Hip Implants
M.U.S.T. Extension
MectaLock Ti Suture Anchor
NextAR TKA Platform My Knee PPS
Surgical Instrument Tray
TWIST PEEK SUTURE ANCHOR
Medacta Shoulder System Short Humeral Diaphysis
PEEK CF PUSH-IN SUTURE ANCHOR
Medacta Anatomic Shoulder Prosthesis
Carefusion Shadow Line System
AMIS K Long
Retractor
Advanced MyHip Planner
MyKnee Cutting Blocks
SMS Cementless Stem
Cannula System
X-Twist Biocomposite Suture Anchor
GMK Revision SC Liners
M.U.S.T. Pedicle Screw System
MPACT Extension - Face Changing Liners
MyKnee UNI-ST
GMK Sphere - Kinematic Alignment
MasterLoc Stem Extension
HS SutureTape
Fastener, Fixation, Nondegradable, Soft Tissue
GMK Total Knee System - TiNbN Coating
GMK-Femoral Distal Augmentations
Quadra-P
SnugFit All-Suture Anchor Extension
OrthoButton CL
GMK Narrow
MectaScope System
MectaLock PEEK® Suture Anchor
MPACT Extension
AMIStem-P Short Neck
NextAR Spine
MOTO Partial Knee & MOTO PFJ Systems Extension
GMK Short Stem
Mbrace Cable
Endo Head
MectaLIF TiPEEK
ActiFlip
NextAR TSA Platform
MasterLoc Stem: Lateralized Plus
NextAR Spine
Awl
Synd-EZ SS
M-Vizion Femoral Revision System
GRAFT FIXATION SYSTEM
GFS
MectaScrew PEEK®
M-Vizion Monobloc
Mecta-C TiPEEK
NextARTM Shoulder Platform
Lateralized Glenosphere
Medacta Bipolar Heads
MyPAO Planning Report
NextAR Spine Platform
Mpact Acetabular System
General orthopedic instruments
Mpact® 3D Metal Implants - DMLS Technology
V-LOX TITANIUM SUTURE ANCHOR
Evolis Total Knee System
Treu GmbH k-wire
DM Converter TiN coated
Twist AP Suture Anchors
MyPAO SA guides
Stripper
KOMET SURGICAL BUR GENERAL & PLASTIC SURGERY
PPEK CF INTERFERENCE SCREW
GMK - Line Extension
MyShoulder Planner
MyKnee PPS-Pin Positioners
Screwdriver
Impactor
Cement Obturator
Glenoid Reconstruction System
Mpact 3D Metal Implants Extension - DMLS Technology
MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MyS
MectaLIF Anterior Stand Alone
Mecta-C
M.U.S.T. MINI Posterior Cervical Screws System Extension
Image Processing
Synd-EZ Ti
MyKnee R Pin Positioners
MOTO Lateral
Versafitcup DM Highcross HXUMWPE
Medacta Total Hip Prosthesis - AMIStem C, Quadra C SN
NextAR RSA Platform
Mpact 3D Metals Augments
GMK Total Knee System- Revision
M.U.S.T. Midline Cortical (MC) Screw System
Medacta Versafitcup CC Trio
Quadra S Stems
Medacta Total Hip System
Quadra R Stems
Quadra H Stems, Quadra C Stems
Surgical Instrument, AC-Powered
SnugFit
MectaLock TI Triple Loaded Suture Anchor
Mpact Double Mobility System
GMK Revision extension
BonePrep kit
Extractor
MySpine Unilateral Guides
MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
PEEK CF PUSH-IN SUTURE ANCHORS
Medacta Shoulder System: Threaded Glenoid Baseplate
Meta + Cement
Surgical Instrument - Elevator
Cement Injector
MectaLIF 3D Metal Anterior
GMK Total Knee System - GMK Revision Hybrid Liners
Sterilization trays
Reamer
MectaLIF Transforaminal
STD Size Wire Case & Tray
SLiK Anchors
Medacta Shoulder System
GFS Ultimate
MyPAO Guides
AMIStem-C
MectaBone-P
GMK 3D Metal Tibial Tray
GMK Sphere Tibial Inserts
Quadra H and R
V-lox Titanium Suture Anchors and Miti Suture Anchors
MectaCer Biolox Delta Heads
Bone screw starter
GMK Resurfacing Patella Size 4
MOTO Partial Knee System Extension
MyShoulder Placement Guides
GMK Sphere Revision
Bone Tap
Versafit Cup Double Mobility Family
GMK Extension
Mectaplug PE II
Ligament Staple
AcTiFlip , GFS Ultimate Hip
PowerKnot High Strength Sutures
MySpine Pedicle Screw Placement Guides - LP
GMK Sphere E-CROSS CR Tibial Inserts, GMK Sphere E-CROSS Flex Tibial Inserts and GMK Sphere E-CROSS Resurfacing Patella
eLIBRA
Depth Gauge
M.U.S.T. Combined Set Screws
MectaBone-P LV
Probe
MOTO Parital Knee System
GMK Hinge
MySpine Cervical Guides
Arthroscopic Instruments
Versafitcup CC Trio - Additional Liners
FairFix Adjustable Button System
Versacem and DM HC Liners
Knotless AP Suture Anchors
MOTO PFJ System
Cement mixing system
Surgical Manual Instrument
MectaLock Suture Anchor Extension
GMK Hinge, GMK Revision
Constrained Liner
Fairfix Adjustable Button System
Mpact 3D Metal Implants and Augments 3D Metal
Mpact Constrained Liner
FairFix Adjustable Button System Extension
SLiK Fix Screw
MectaCer BIOLOX forte Femoral Heads
Quadra C stems
Medacta Shoulder System - Reverse
MectaLIF Extension
MectaLIF Anterior Simple
GMK Total Knee System
Traction Instrument
Drill Bit
GMK Sphere Extension
Surgical Instrument - Hook
9604UK Gaston sleeve
PAO Cortical Screw
MectaLIF Anterior Lag
M.U.S.T. Mini Posterior Cervical Screw System
M.U.S.T. Mini Extension
B-Screw
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Foreign Private Label Distributor