FDA Registration
Active
🇨🇭 Switzerland
MEDACTA INTERNATIONAL SA
Reg #: 3008110533
·
FEI: 3008110533
·
Expires 2026
Products
106
Proprietary Names
283
Establishment Types
6
Classifications
106
Registration Details
- Registration Name
- MEDACTA INTERNATIONAL SA
- Registration Number
- 3008110533
- FEI Number
- 3008110533
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Alla Rossa 6
- City
- Rancate Ticino
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K021765
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 |
|---|---|---|---|---|---|
| Prosthesis, Hip, Cement Restrictor | JDK | Class 2 | General, Plastic Surgery | No | 2022-11-23 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2021-02-22 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2021-02-22 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2008-02-25 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2010-04-16 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-01-21 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2020-03-09 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2021-03-02 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-06-11 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2020-02-19 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2023-02-10 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2022-07-22 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2015-05-07 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2021-03-26 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2021-03-26 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2021-03-26 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2014-09-12 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2014-09-12 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2017-05-25 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2017-05-25 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2017-05-25 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2010-03-30 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2024-06-13 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2020-09-18 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2020-09-18 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2020-11-07 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2023-01-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2016-05-22 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2010-04-02 |
| Orthopedic Augmented Reality | SBF | Class 2 | Neurology | No | 2025-09-05 |
| Cement Obturator | LZN | Class 2 | General, Plastic Surgery | No | 2023-02-21 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2021-10-13 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2021-10-13 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2022-08-24 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2023-05-31 |
| Pedicle Screw Placement Guide | PQC | Class 2 | Orthopedic | No | 2023-07-22 |
| Sacroiliac Screw Placement Guide | QSR | Class 2 | Orthopedic | No | 2023-07-22 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2025-06-12 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2017-06-09 |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | Class 1 | Orthopedic | No | 2023-01-05 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-01-19 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-01-19 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2024-05-04 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2020-02-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2020-12-28 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2020-08-12 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-03-25 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2022-10-25 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2023-01-05 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2022-02-17 |
| Motor, Surgical Instrument, Pneumatic Powered | GET | Class 1 | General, Plastic Surgery | No | 2008-06-04 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2021-11-16 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2019-07-11 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2008-02-11 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2021-01-13 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2021-01-13 |
| Shoulder Arthroplasty Implantation System | QHE | Class 2 | Orthopedic | No | 2025-02-03 |
| 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 |
| Intraoperative Orthopedic Joint Assessment Aid | ONN | Class 2 | Neurology | No | 2011-01-28 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-01-05 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2020-02-10 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2025-09-15 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2009-01-22 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2023-01-16 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2014-10-27 |
| Evacuator, Vapor, Cement Monomer | JDY | Class 1 | Orthopedic | No | 2022-01-11 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2025-06-12 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2025-08-22 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2010-03-30 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2025-08-04 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-06-12 |
| Probe | HXB | Class 1 | Orthopedic | No | 2023-01-16 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2024-06-14 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2022-01-11 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2018-12-05 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2025-06-12 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2025-06-20 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2023-01-05 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2025-04-16 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2023-01-16 |
| Table, Operating-Room, Mechanical | FWX | Class 1 | General, Plastic Surgery | No | 2008-02-11 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2023-01-05 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2025-06-12 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2010-03-30 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2025-06-12 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2020-10-05 |
| Punch, Femoral Neck | HWP | Class 1 | Orthopedic | No | 2023-01-05 |
| Posterior Cervical Screw Placement Guide | QSD | Class 2 | Orthopedic | No | 2023-12-08 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2018-05-08 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2019-07-24 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2025-07-02 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2025-06-12 |
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2023-02-10 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2023-01-05 |
Proprietary Names
BonePrep kit
Retractor
MectaLock Suture Anchor Extension
MectaCer BIOLOX forte Femoral Heads
Quadra C stems
MyKnee Cutting Blocks
Surgical Instrument - Hook
Advanced MyHip Planner
MectaLIF Anterior Simple
GMK - Line Extension
FairFix QT Adjustable Button
GMK Revision & Hinge Extension - TiNbN Coating
GMK Hinge
PEEK CF PUSH-IN SUTURE ANCHOR
AcTiFlip , GFS Ultimate Hip
ORTHOPEDIC DISPOSABLE SURGICAL NEEDLE
Sterilization trays
Synd-EZ SS
DM Converter TiN coated
Mecta-C TiPEEK
MectaLIF Transforaminal
Versacem and DM HC Liners
Humeral Eccentric Reverse Metaphysis
Mecta-C
Treu GmbH k-wire
M.U.S.T Pedicle Screw System
Cement mixing system
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
SMS Cementless Stem
Rasp
Constrained Liner
Mecta-C Stand Alone Extension
SnugFit
Extractor
PEEK CF PUSH-IN SUTURE ANCHORS
MasterLoc
GMK-SPHERE Spherika Femurs and Tibial Trays Plus
Mecta-C Cervical Plate
Versafitcup CC Trio extension
iMNS Medacta Navigation System
Coated Hip Implants
Image Processing
NextARTM Shoulder Platform
Mecta-C TiPEEK with titanium markers
Mecta-C with titanium markers
Medacta Anatomic Shoulder Prosthesis
GMK Revision SC Liners
Cement Obturator
Twist AP Suture Anchors
MSS Monobloc stem
Mectacem-X (With Gentamicin)
GMK 3D Metal Tibial Tray
MyPAO Guides
MectaScrew Extension
GMK Short Stem
GMK Narrow
V-LOX TITANIUM SUTURE ANCHOR
NextAR Spine Platform
MySpine Unilateral Guides
NextAR TKA Platform My Knee PPS
DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
SLiK Fix Screw
Bone screw starter
Medacta Shoulder System: Threaded Glenoid Baseplate
Intradisk; K-Wire; Renova Spine Kyphoplasty Kirschner Guide
M-ARS ACL: Anatomic Ribbon Surgery System
GMK Extension
OrthoButton CL
Spinal Instrument
M.U.S.T. Pedicle Screw System
Mbrace Cable
M.U.S.T. MINI Posterior Cervical Screws System
MasterLoc Stem: Lateralized Plus
Quadra-P
Lateralized Glenosphere
MectaLock TI Triple Loaded Suture Anchor
Knotless AP Suture Anchors
FairFix Adjustable Button System Extension
M.U.S.T. Midline Cortical (MC) Screw System
GMK Full PE Tibial Components
GMK Sphere
MITI TITANIUM SUTURE ANCHOR
Medacta Shoulder System
Versafit Cup Double Mobility Family
M.U.S.T. Extension
MectaLIF Anterior Extension
Reamer
Shoulder System - TiNbN Coating
9604UK Gaston sleeve
Medacta Shoulder System - Reverse
Quadra S Stems
Medacta Total Hip System
Quadra R Stems
Quadra H Stems, Quadra C Stems
M.U.S.T. Mini Posterior Cervical Screw System
MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MyS
IMT Motorized broach
Gaston
Mectacer Biolox Option Heads
M-Vizion Femoral Revision System Extension
MiniMAX
GMK Total Knee System
NextAR RSA Platform
AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
AMIStem-P Short Neck
MyShoulder Placement Guides
GMK Sphere Tibial Inserts
MOTO Partial Knee & MOTO PFJ Systems Extension
KOMET SURGICAL BUR GENERAL & PLASTIC SURGERY
MectaLIF Extension
Curette
Manual Orthopedic Instruments
MectaLIF 3D Metal
Surgical Instrument, AC-Powered
Medacta Shoulder System Short Humeral Diaphysis
MOTO Lateral
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
MyShoulder Planner
MOTO PFJ System
Mpact Acetabular System
MyHip Planner & Verifier
Mpact Extension
Medacta Versafitcup CC Trio
Mpact DM Converter
eLIBRA
Versafitcup DM Highcross HXUMWPE
AMIStem-C
MectaCer Biolox Delta Heads
AMIS K Long
Screwdriver
MectaFix CL Fixation Button with Continuous Loop
SnugFit All-Suture Anchor
MOTO Parital Knee System
NextAR Spine
GFS BTB
PowerKnot High Strength Sutures
GMK Sphere E-CROSS CR Tibial Inserts, GMK Sphere E-CROSS Flex Tibial Inserts and GMK Sphere E-CROSS Resurfacing Patella
Osteotome
M-Vizion Monobloc
Mpact 3D Metal Implants Extension - DMLS Technology
Carefusion Shadow Line System
Vacuum Pump
GFS Ultimate
GFS
Quadra H and R
MPACT Extension - Face Changing Liners
M.U.S.T. Mini Extension
ActiFlip
Mpact 3D Metal Implants and Augments 3D Metal
Stripper
GMK Sphere Revision
MectaLIF Anterior Lag
Surgical Manual Instrument
MectaBone-P Injection System
Injector Instrumentation
Cortical Fixation Systems
MectaScrew PEEK®
GMK Hinge, GMK Revision
Access kit
B-Screw
Mpact Constrained Liner
Mpact® 3D Metal Implants - DMLS Technology
GMK-Femoral Distal Augmentations
MOTO Partial Knee System Extension
MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
Evolis Total Knee System
Mpact Double Mobility System
V-LOX PEEK CF SUTURE ANCHOR
MectaLIF Anterior Stand-Alone
MectaLock PEEK® Suture Anchor
Clamp
MySpine Pedicle Screw Placement Guides - LP
Drill Bit
Probe
Cannula System
MSS - Humeral reverse liners extension
TWIST PEEK SUTURE ANCHOR
Quadra C
Titanium Interference Screw
Mpact 3D Metals Augments
Meta + Cement
PPEK CF INTERFERENCE SCREW
Versafitcup CC Trio - Additional Liners
Cement Injector
M-Vizion Femoral Revision System
MectaLIF Anterior Stand Alone
MectaLIF Transforaminal TiPEEK
M.U.S.T. Combined Set Screws
Arthroscopic Instruments
FairFix Adjustable Button System
Mpres Neck Preserving Stem
MasterLoc Stem Extension
Bone Tap
Mfinity Femoral System
NextAR Spine
MySpine WebPlanner & MyBalance
Fastener, Fixation, Nondegradable, Soft Tissue
GMK Revision extension
Impactor
Mectacem-X
M.U.S.T. Pedicle Screw Extension and Long Tab Implants
Depth Gauge
Medacta Bipolar Heads
MectaLIF Anterior
MectaLIF 3D Metal Anterior
M.U.S.T. MINI Posterior Cervical Screws System Extension
Surgical Instrument Tray
Surgical Instrument - Elevator
AMIStem and Quadra - Line Extension
MectaTap TI Suture Anchor
MectaLIF
GRAFT FIXATION SYSTEM
3DMetal Diaphyseal Femoral Cones
GMK Total Knee System- Revision
MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
MyKnee R Pin Positioners
Knotless PEEK and PEEK CF Push-In Suture Anchor
Medacta Bone Screws
Total Hip Prosthesis System ¿ CoCr Line Extension
Ligament Staple
MectaLIF TiPEEK
General orthopedic instruments
3DMetal Tibial Cones
NextAR TKA Platform
AMIS Table
MectaLock Ti Suture Anchor
SLiK Anchors
MyPAO SA guides
Mectaplug PE II
Surgical Instrument
MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments
GMK Resurfacing Patella Size 4
Glenoid Reconstruction System Full Wedge Baseplate
Traction Instrument
Glenoid Reconstruction System
HS SutureTape
MPACT Extension
MectaBone-P LV
Medacta Total Hip Prosthesis - AMIStem C, Quadra C SN
ATLAS
MectaBone-G
Reverse Shoulder
Passer
PowerSuture
MectaScope System
GMK Total Knee System - TiNbN Coating
M.U.S.T. Pedicle Screw System - Extension
AMIStem H;
Quadra S and H Stems
Punch
MySpine Cervical Guides
MyPAO Planning Report
X-Twist Biocomposite Suture Anchor
GMK Total Knee System - GMK Revision Hybrid Liners
M.U.S.T. Pedicle Screw System Extension
SecureFix Meniscus Repair
V-lox Titanium Suture Anchors and Miti Suture Anchors
MectaLIF Posterior Extension
MectaLock All-Suture Anchors
NextAR TSA Platform
MectaQTH
STD Size Wire Case & Tray
Awl
MySpine Pedicle Screw Placement Guides
PAO Cortical Screw
Sterilization tray
MectaBone-P
NextAR Hip Platform
MyKnee UNI-ST
Rongeur
Endo Head
GMK Sphere Extension
Synd-EZ Ti
PULLUP Adjustable Juxtacortical Fixation Device
GMK 3D Metal Tibial Tray Extension
MyKnee PPS-Pin Positioners
GMK Sphere - Kinematic Alignment
GMK Sphere & GMK SpheriKA Cementless
Mecta-C Stand Alone
SnugFit All-Suture Anchor Extension
Fairfix Adjustable Button System
Titanium Interference Screws
X-Twist PEEK Suture Anchor
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
Foreign Private Label Distributor
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility