FDA Registration
Active
🇳🇱 Netherlands
OTN Implants B.V.
Reg #: 3015679904
·
FEI: 3015679904
·
Expires 2026
Products
4
Proprietary Names
13
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- OTN Implants B.V.
- Registration Number
- 3015679904
- FEI Number
- 3015679904
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Broach | HTQ | Class 1 | Orthopedic | No | 2019-08-16 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2019-08-16 |
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 2019-08-16 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2019-08-16 |
Proprietary Names
OTNI CR01
OTNI CR02
OTNI RR02
OTNI RR01
OTNI RR03
OTNI 1307
OTNI 1310
OTNI 1308
OTNI 1311
OTNI 13BS
OTNI 13TR
OTNI 1309
OTNI 1306
Establishment Types
Manufacture Medical Device
Foreign Private Label Distributor