FDA Registration
Active
🇨🇭 Switzerland
OSTEONICS BONE TAP
Reg #: 8031020
·
FEI: 3002807830
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- STRYKER GmbH
- Registration Number
- 8031020
- FEI Number
- 3002807830
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BOHNACKERWEG 1
- City
- SELZACH Solothurn
- Country
- CH
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 |
|---|---|---|---|---|---|
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2007-06-05 |
Proprietary Names
OSTEONICS BONE TAP
PEEK IntraLine Anchor System
Bioabsorable Wedge Interference Screw System
Biosteon IntraLine System
Biosteon Wedge Interference Screw System
STRYKER COMBO PUNCH
TAP
MaxTorque, DRLock Extreme
General Instruments
AxSOS
AxSOS 3
Variable Angle Fixation
Pangea Platform
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device