FDA Registration
Active
🇺🇸 United States
C&W SWISS, INC.
Reg #: 3004635447
·
FEI: 3004635447
·
Expires 2026
Products
35
Proprietary Names
26
Establishment Types
1
Classifications
35
Registration Details
- Registration Name
- C&W SWISS, INC.
- Registration Number
- 3004635447
- FEI Number
- 3004635447
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 LAU PKWY
- City
- CLAYTON
- State
- OH
- ZIP
- 45315
- Country
- US
Owner / Operator
- Firm Name
- C&W SWISS, INC.
- Operator Number
- 9063235
- Address
- 100 Lau Parkway, --
- City
- Clayton
- State
- OH
- Postal Code
- 45315
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-28 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-01-28 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-28 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-28 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-28 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2022-01-27 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-01-27 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-02-12 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2013-01-23 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2022-01-27 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2022-01-27 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2025-05-27 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-12-18 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2022-01-27 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-01-27 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2013-01-28 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-23 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-12-18 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-01-23 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-23 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-23 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2023-12-11 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2023-01-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-11-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2018-11-12 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2018-11-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2018-11-12 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2018-11-12 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2018-11-12 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2018-11-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2018-11-12 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-02-12 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-02-12 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2013-01-28 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-09-17 |
Proprietary Names
Spreader Pin A, Spreader Pin B, Spreader Pin C, Spreader Pin D
Pin to Rod Clamp Fastener, Foot Plate Bolt, Calcaneus Pin Hook Fastener, Calcaneus Pin Hook
TM Ankle Angle Locking Pin, Rail Hole Stabilizer
ZIMMER TRABECULAR METAL TOTAL ANKLE
Pyrenees, Blue Ridge
Range, Mesa, Denali, Natural Bridge
Aleutian
Range, Ari
Cayman Buttress
Everest
PLATE, FIXATION, BONE, SCREW, FIXATION, BONE
Range Small Stature, Mesa
Caspian, Mesa mini, Denali mini
PRESIDIO
CoCr Wire, Nile
Santorini
Pyrenees
Chesapeake Cervical
Cayman Thoracolumbar
Chesapeake Lumbar
CPT 12/14 TAMP ASSY SIZE 1
PLATE, FIXATION, BONE
DYNA-LINK
Rox, Fixation, Intramedullary and Accessories
CPT 12/14 TAMP ASSY SIZE 2
Range Pediatric
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)