FDA Registration
Active
🇫🇷 France
IMPLANET
Reg #: 3007675554
·
FEI: 3007675554
·
Expires 2026
Products
14
Proprietary Names
14
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- IMPLANET
- Registration Number
- 3007675554
- FEI Number
- 3007675554
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Technopole Bordeaux Montesquieu, Allee Francois Magendie
- City
- Martillac Nouvelle-Aquitaine
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K192084
Owner / Operator
- Firm Name
- IMPLANET
- Operator Number
- 10041401
- Address
- Technopole Bordeaux Montesquieu, Allee Francois Magendie
- City
- Martillac
- State
- Nouvelle-Aquitaine
- Postal Code
- 33650
- Country
- FR
- Correspondent
- Regis LE COUEDIC
US Agent
- Business Name
- Implanet America Inc
- Contact Name
- Shane Doyle
- Address
- 1661 International Dr Ste 400
- City
- Memphis
- State
- TN
- ZIP
- 38120
- Country
- US
- [email protected]
- Phone
- 855 4444675
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-12-06 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2012-07-19 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2012-07-19 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2012-07-19 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2012-07-19 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2013-10-28 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2019-08-28 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2026-03-05 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-09-13 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2023-05-05 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-03-14 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-06-07 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-09-13 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-03-14 |
Proprietary Names
MADISON Total Knee System
IMPLANET SPINE SYSTEM (CALYPSO)
IMPLANET SPINE SYSTEM
JAZZ Systems
JAZZ System
SWINGO-3D
JAZZ FRAME
JAZZ SPINAL SYSTEM
JAZZ
JAZZ LOCK
Implanet Spine System
SQUALE
ORIGIN
JAZZ SYSTEM
Establishment Types
Manufacture Medical Device