FDA Registration
Active
🇨🇭 Switzerland
RUETSCHI TECHNOLOGY AG
Reg #: 3005827567
·
FEI: 3005827567
·
Expires 2026
Products
19
Proprietary Names
31
Establishment Types
1
Classifications
19
Registration Details
- Registration Name
- RUETSCHI TECHNOLOGY AG
- Registration Number
- 3005827567
- FEI Number
- 3005827567
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Fabrikstrasse 35
- City
- Muntelier Fribourg
- Country
- CH
Owner / Operator
- Firm Name
- Ruetschi Technology AG
- Operator Number
- 10043785
- Address
- Fabrikstrasse 35
- City
- Muntelier
- State
- Fribourg
- Postal Code
- 3286
- Country
- CH
- Correspondent
- Adrian Hofer
US Agent
- Business Name
- ONYX MEDICAL CORPORATION
- Contact Name
- JODIE GILMORE
- Address
- 1800 North Shelby Oaks Drive
- City
- Memphis
- State
- TN
- ZIP
- 38134
- Country
- US
- [email protected]
- Phone
- 901 3236699
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2022-11-16 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-11-16 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2018-09-10 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-05-25 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-05-25 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2024-08-19 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-05-17 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2021-11-10 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2021-11-10 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-05-07 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2022-11-16 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-11-16 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2020-03-19 |
| Probe | HXB | Class 1 | Orthopedic | No | 2022-11-16 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2018-05-07 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2018-05-07 |
| Bender | HXW | Class 1 | Orthopedic | No | 2024-01-23 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2024-01-23 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2020-01-24 |
Proprietary Names
NEO Pedicle Screw System
APTUS Wrist 2.5 System
Neo Pedicle Screw System
APTUS K-Wire System
APTUS Cannulated Compression Screws
APTUS headed Cannulated Compression Screws
T-Handle Kit
Removal Kit
Compressor Distractor Kit
Pedicle Screw Instrument Kit
K-wire Kit
Rod bender
NEO Cage System
PALAMIX Cement Gun
Cement Pusher
Steffee
Tap kit for Neo Pedicle Screw System
APTUS Ankle Trauma System 2.8/3.5
Rod Bender NS
Lateral retractor kit 140mm
Posterior retractor kit 40mm
Posterior retractor kit 70mm
Posterior retractor kit 50mm
Lateral retractor kit 180mm
Lateral retractor kit 120mm
Posterior retractor kit 80mm
Posterior retractor access kit
Lateral retractor access kit
Posterior retractor kit 60mm
Lateral retractor kit 160mm
APTUS Foot System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)