FDA Registration
Active
🇩🇪 Germany
RHIZOSPLINT
Reg #: 3005083016
·
FEI: 3005083016
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- SPORLASTIC GMBH & Co.KG
- Registration Number
- 3005083016
- FEI Number
- 3005083016
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Weberstr. 1
- City
- NURTINGEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- SPORLASTIC GMBH
- Operator Number
- 9033265
- Address
- WEBERSTRASSE 1, --
- City
- NUERTINGEN
- State
- Baden-Wurttemberg
- Postal Code
- D-72622
- Country
- DE
- Correspondent
- WALTER MICHAEL - LEUTHE
US Agent
- Business Name
- United Ortho, INC.
- Contact Name
- Andy Opliger
- Address
- 2235 Pennsylvania Street
- City
- Fort Wayne
- State
- IN
- ZIP
- 46803
- Country
- US
- [email protected]
- Phone
- 800 2278748
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2018-07-27 |
Proprietary Names
RHIZOSPLINT
RHIZO-RING SOFT
SWEDE-O-UNIVERSAL X8
RHIZO-HiT CLASSIC
RHIZO-HiT
CALCALASTIC
ELASTIC THUMB SUPPORT
THUMB SADDLE JOINT BRACE
OMO-HiT
ARTHROFIX
OMO-LUX
CALCALASTIC LONG
NEURO-LUX II
RHIZO-RING
STUTTGART SHOULDER-ARM SUPPORT
SWEDE-O-UNIVERSAL
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device