FDA Registration
Active
🇳🇱 Netherlands
OTNI1709 OTNI Luci Male Part
Reg #: 3015679904
·
FEI: 3015679904
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OTN Implants B.V.
- Registration Number
- 3015679904
- FEI Number
- 3015679904
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Griftdijk 105
- City
- Nijmegen Gelderland
- Country
- NL
Owner / Operator
- Firm Name
- OTN Implants B.V.
- Operator Number
- 10061094
- Address
- Simon Stevinweg 48
- City
- Arnhem
- State
- Gelderland
- Postal Code
- 6827BT
- Country
- NL
- Correspondent
- Pamela C Musch
US Agent
- Business Name
- ST&G USA CORP.
- Contact Name
- Glenn Choi
- Address
- 2691 Saturn St
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 714 5240663
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 2019-08-16 |
Proprietary Names
OTNI1709 OTNI Luci Male Part
OTNI1422 OTNI M12 Screw
OTNI 16 OTNI Puller
OTNI 17 Luci Connector Set
OTNI 17XX OTNI Offsetplate XXmm
Establishment Types
Export Device to the United States But Perform No Other Operation on Device