FDA Registration
Active
🇩🇪 Germany
Pirogoff-Foot
Reg #: 8010401
·
FEI: 5812
·
Expires 2025
Products
1
Proprietary Names
36
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- STREIFENEDER ortho.production gmbH
- Registration Number
- 8010401
- FEI Number
- 5812
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- MOOSFELDSTRASSE 10
- City
- EMMERING Bavaria
- Country
- DE
Owner / Operator
- Firm Name
- Streifeneder ortho.production GmbH
- Operator Number
- 8010401
- Address
- MOOSFELDSTRASSE 10, --
- City
- EMMERING, BAVARIA
- State
- DE-BY
- Postal Code
- 82275
- Country
- DE
US Agent
- Business Name
- Fabtech Systems LLC.
- Contact Name
- Greg Mattson
- Address
- 3304 Hill Avenue
- City
- Everett
- State
- WA
- ZIP
- 98201
- Country
- US
- [email protected]
- Phone
- 425 3499557
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2018-10-18 |
Proprietary Names
Pirogoff-Foot
S.A.C.H. Foot for Men for 175 kg with adapter
S.A.C.H. Foot
Single-Axis-Foot Adapter
Geriatric-Single-Axis-Foot
S.A.C.H. Foot for Bathing
Single-Axis-Foot
S.A.C.H. Foot Adapter -Titanium-
GO.free Carbon Module
Ankle Block -PUR- light
GO.free Carbon Foot
S.A.C.H. Foot with Split Toe
Ankle Block -poplar wood-
S.A.C.H. Foot for Men for 225 kg with adapter
S.A.C.H. Foot Adapter -Aluminum-
S.A.C.H. Foot with Toes for Children
Connection Cap for single-axis-foot
Ankle Block -wood-
GO.smart Carbon Module
Dynamic Foot with split toe
GO.smart Carbon Foot
Dynamic Foot with closed toe
S.A.C.H. Foot for Men up to 150 kg with Adapter
Geriatric-Foot light
S.A.C.H. Foot Adapter -Stainless Steel-
S.A.C.H. Foot Adapter -Stainless Steel- 150 kg
GO.relax Carbon Module
GO.adventure Carbon Module
GO.adventure Carbon Foot
Connection Cap for Carbon Foot GO.
SACH Foot for Children with Split Toe
Foot Shell for Carbon Foot GO.
Wedge set for Carbon Foot GO.free
GO.relax Carbon Foot
Spectra Sock(s) for Carbon Foot GO.
Wedge set for Carbon Foot GO.adventure
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device