FDA Registration
Active
🇨🇭 Switzerland
SPITREX ORTHOPEDICS SWITZERLAND SA
Reg #: 3011500362
·
FEI: 3011500362
·
Expires 2026
Products
16
Proprietary Names
123
Establishment Types
1
Classifications
16
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Registration Details
- Registration Name
- SPITREX ORTHOPEDICS SWITZERLAND SA
- Registration Number
- 3011500362
- FEI Number
- 3011500362
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Girardet 29
- City
- Le Locle Neuchatel
- Country
- CH
Owner / Operator
- Firm Name
- SPITREX ORTHOPEDICS SWITZERLAND SA
- Operator Number
- 10047874
- Address
- Girardet 29
- City
- Le Locle
- State
- Neuchatel
- Postal Code
- 2400
- Country
- CH
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2014-11-11 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-11-10 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2014-11-11 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2014-11-11 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2014-11-11 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2020-11-25 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2022-11-10 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2022-11-10 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2022-11-10 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2022-11-10 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2023-01-03 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2023-01-03 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2023-01-03 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2023-01-03 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2022-11-10 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-11-10 |
Proprietary Names
ACE OPEN-BACK HALO RING
ACE 3.5MM CORTICAL BONE SCREW
ACE PROXIMAL HUMERAL NAIL SYSTEM - VERSANAIL
DEPUY ACE TIMAX META PLATE
ACE RECONSTRUCTIVE PLATE
ACE/KYLE CAPTURED HIP SCREW
ACE CORTICAL BONE SCREW
ALPS Total Foot System - CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824
Tyber Medical Anatomical Plating System
TM Plating System (Proximal Femur)
SMALL FRAGMENT LOCKING PLATING SYSTEM
TROCHANTERIC NAIL
ALPS HANS SYSTEM-SMALL BONE LOCKING PLATING SYSTEM
POLYAX LOCKED PLATING SYSTEM
ALPS
Screw, fixation, bone
ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM -VERSANAIL
ALPS Proximal Tibia Plating System
ACE BROOKER BONE PLATING SYSTEM
DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
ACE AIM TTC FUSION NAIL - CORTICAL SCREW
DIST TIB MEDIAL LT 9H
DIST TIB MEDIAL LT 15H
LOCKING DIST TIB MEDIAL LT 6H
LOCKING DIST TIB MEDIAL LT 12H
LOCKING DIST TIB MEDIAL RT 6H
DIST TIB MEDIAL RT 15H
BIOMET INC
LOCKING DIST TIB MEDIAL RT 12H
DIST TIB MEDIAL RT 9H
ACE BIO WIN TIBIAL NAILING SYSTEM
CORTICAL LOCKING SCREWS
ZINDRICK IM ROD -SCREW CORTICAL
Tyber Medical Distal Radius Plating System
LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM - CORT LOCK SCRW
ACE CANCELLOUS BONE SCREW
DEPUY ACE VERSANAIL TIBIAL NAIL
THACKRAY TITANIUM MINI-PLATING SYSTEM - CORTICAL SCREW
AIM SUPRACONDYLAR NAIL - SOLID END CAP
ALPS Total Foot System -DEPUY FRACTURE AND FUSION PLATING SYSTEM
ANATOMIC LOCKING PLATING SYSTEM
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTE - CANC LOCK SCRW
DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL - ENDCAP IMPING
DEPUY ACE TK2 HIP SCREW SYSTEM -LOCKING CORTICAL SCREW
ACE CANCELLOUS BONE SCREW - VERSANAIL
ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW
ACE VERSANAIL
ACE MULTIPLE PIN PLATE -BUTTRESS PLATE
ACE SOLID CANCELLOUS BONE SCREW
ACE HUMERUS & RADIUS PLATES
ACE AIM TIBIAL NAIL - END CAP
MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
TROCHANTERIC NAIL SYSTEM -ATN
ALPS Fibula Plating System
ACE REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW
HDLS CMPN SCR 3X14 NS
TWIST-OFF SCR 2X9 NS
HDLS CMPN SCR 2.5X22 NS
TWIST-OFF SCR 2.7X24 NS
HDLS CMPN SCR 3X38 NS
HDLS CMPN SCR 3X28 NS
HDLS CMPN SCR 3X18 NS
HDLS CMPN SCR 3X16 NS
HDLS CMPN SCR 3X12 NS
HDLS CMPN SCR 3X22 NS
HDLS CMPN SCR 2.5X36 NS
HDLS CMPN SCR 2.5X40 NS
TWIST-OFF SCR 2X13 NS
HDLS CMPN SCR 2.5X28 NS
TWIST-OFF SCR 2.7X22 NS
HDLS CMPN SCR 2.5X20 NS
HDLS CMPN SCR 3X32 NS
HDLS CMPN SCR 3X30 NS
HDLS CMPN SCR 2.5X24 NS
HDLS CMPN SCR 2.5X26 NS
TWIST-OFF SCR 2.7X16 NS
TWIST-OFF SCR 2X11 NS
HDLS CMPN SCR 2.5X38PT NS
HDLS CMPN SCR 2.5X12 NS
HDLS CMPN SCR 2.5X30PT NS
HDLS CMPN SCR 2.5X38 NS
HDLS CMPN SCR 2.5X28PT NS
TWIST-OFF SCR 2X14 NS
TWIST-OFF SCR 2.7X20 NS
HDLS CMPN SCR 3X36 NS
HDLS CMPN SCR 2.5X32PT NS
HDLS CMPN SCR 3X24 NS
TWIST-OFF SCR 2.7X15 NS
HDLS CMPN SCR 3X40 NS
HDLS CMPN SCR 2.5X10 NS
TWIST-OFF SCR 2.7X18 NS
HDLS CMPN SCR 2.5X16 NS
HDLS CMPN SCR 3X20 NS
TWIST-OFF SCR 2.7X8 NS
HDLS CMPN SCR 3X34 NS
HDLS CMPN SCR 2.5X40PT NS
HDLS CMPN SCR 2.5X32 NS
HDLS CMPN SCR 2.5X18 NS
TWIST-OFF SCR 2.7X9 NS
TWIST-OFF SCR 2X12 NS
TWIST-OFF SCR 2.7X12 NS
HDLS CMPN SCR 3X26 NS
HDLS CMPN SCR 2.5X36PT NS
HDLS CMPN SCR 3X10 NS
TWIST-OFF SCR 2.7X13 NS
TWIST-OFF SCR 2X8 NS
HDLS CMPN SCR 2.5X34 NS
TWIST-OFF SCR 2.7X10 NS
HDLS CMPN SCR 2.5X14 NS
HDLS CMPN SCR 2.5X34PT NS
TWIST-OFF SCR 2.7X11 NS
TWIST-OFF SCR 2.7X14 NS
TWIST-OFF SCR 2X10 NS
HDLS CMPN SCR 2.5X30 NS
TWIST-OFF SCR 2X15 NS
Biomet Cann screw system
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
PE.R.I. II KNEE FRACTURE SYSTEM
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS - VERSANAIL
MULTIPLICITY OF PRODUCTS
ZINDRICK IM ROD INSTRUMENTS - END CAP
Pro-X1®
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)