FDA Registration
Active
🇫🇷 France
Everest, Range, Mesa, Denali
Reg #: 9617544
·
FEI: 3003112432
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- STRYKER SPINE
- Registration Number
- 9617544
- FEI Number
- 3003112432
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ZONE INDUSTRIELLE DE MARTICOT
- City
- CESTAS Nouvelle-Aquitaine
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K181603
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2018-12-06 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2018-12-06 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2018-12-06 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2018-12-06 |
Proprietary Names
Everest, Range, Mesa, Denali
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)