FDA Registration
Active
🇫🇷 France
VersiTomic Low Profile Reamer9.5 mm
Reg #: 3000931034
·
FEI: 3000931034
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Tornier S.A.S.
- Registration Number
- 3000931034
- FEI Number
- 3000931034
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 161 rue Lavoisier
- City
- Montbonnot Saint-Martin Isere
- Country
- FR
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 |
|---|---|---|---|---|---|
| Reamer | HTO | Class 1 | Orthopedic | No | 1992-11-23 |
Proprietary Names
VersiTomic Low Profile Reamer9.5 mm
VersiTomic Low Profile Reamer10 mm
VersiTomic Low Profile Reamer10.5 mm
VersiTomic Low Profile Reamer9 mm
VersiTomic Low Profile Reamer8.5 mm
VersiTomic Low Profile Reamer13 mm
INFINITY
VersiTomic Low Profile Reamer5.5 mm
VersiTomic Low Profile Reamer7 mm
VersiTomic Low Profile Reamer5 mm
Tornier Radial Head System
VersiTomic Low Profile Reamer6 mm
VersiTomic Low Profile Reamer8 mm
VersiTomic Low Profile Reamer6.5 mm
VersiTomic Low Profile Reamer11 mm
VersiTomic Low Profile Reamer4.5 mm
VersiTomic Low Profile Reamer12 mm
VersiTomic Low Profile Reamer7.5 mm
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device