FDA Registration
Active
🇧🇷 Brazil
NEOORTHO PRODUTOS ORTOPEDICOS S/A
Reg #: 3009158523
·
FEI: 3009158523
·
Expires 2026
Products
28
Proprietary Names
9
Establishment Types
2
Classifications
28
Registration Details
- Registration Name
- NEOORTHO PRODUTOS ORTOPEDICOS S/A
- Registration Number
- 3009158523
- FEI Number
- 3009158523
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rua Angelo Domingos Durigan, 607, Cascatinha
- City
- Curitiba Parana
- Country
- BR
Regulatory Submissions
- 510(k) Number
- K102641
Owner / Operator
- Firm Name
- NEOORTHO Produtos Ortopedicos S/A
- Operator Number
- 10036684
- Address
- Rua Angelo Domingos Durigan, 607, Cascatinha
- City
- Curitiba
- State
- Parana
- Postal Code
- 82025-100
- Country
- BR
- Correspondent
- Elaine Patricia Thome Rossetto
US Agent
- Business Name
- Visionare LLC
- Contact Name
- Marina Adami
- Address
- 12220 ITEC Haul Dr, Units 215 / 216, Fort Myers, FL
- City
- Fort Myers
- State
- FL
- ZIP
- 33913
- Country
- US
- [email protected]
- Phone
- 239 4065674
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2014-08-26 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2011-05-19 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2011-05-19 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2011-05-19 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2011-05-19 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2011-05-19 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2014-08-26 |
| Template | HWT | Class 1 | Orthopedic | No | 2011-05-19 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2014-08-26 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2011-05-19 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2014-12-08 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2011-05-19 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2014-08-26 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2011-05-19 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2023-11-13 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-08-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2014-12-08 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2014-12-17 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2014-12-17 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2011-05-19 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2011-05-19 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2011-05-19 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2023-05-18 |
| Plastic Surgery And Accessories Kit | FTN | Class 1 | General, Plastic Surgery | No | 2011-12-07 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2017-07-19 |
| Probe | HXB | Class 1 | Orthopedic | No | 2014-08-26 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2011-05-19 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2011-05-19 |
Proprietary Names
Neoortho
Mini and Micro Fragments Reconstruction System - NEOFACE
Femoral Trochanteric Nail System - Neonail
Mini and Micro Fragments Reconstruction System-Neofix
Intramedullary Nail and Screws - NEONAIL
Small and Large Fragments Osteosynthesis System NEOFIX
Visionare
CranioMaxillofacial Fixation (CMF) System - CMF Visionare
Cannulated Screws Neoortho
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)