FDA Registration
Active
🇫🇷 France
MARLE FINISHING SAS
Reg #: 3012275107
·
FEI: 3012275107
·
Expires 2026
Products
21
Proprietary Names
1
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- MARLE FINISHING SAS
- Registration Number
- 3012275107
- FEI Number
- 3012275107
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 443 Rue Rene Cassin
- City
- La Talaudiere Loire
- Country
- FR
Owner / Operator
- Firm Name
- MARLE FINISHING SAS
- Operator Number
- 10050105
- Address
- 443 rue Rene Cassin
- City
- LA TALAUDIERE
- State
- Loire
- Postal Code
- 42350
- Country
- FR
US Agent
- Business Name
- Tangible Solutions Inc. dba Marle Tangible
- Contact Name
- Kriss Anderson
- Address
- 678 Yellow Springs Fairfield Rd
- City
- Fairborn
- State
- OH
- ZIP
- 45324
- Country
- US
- [email protected]
- Phone
- 937 9124603
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2026-03-20 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2025-06-10 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-04-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-02-15 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2020-07-30 |
| Ankle Arthroplasty Implantation System | OYK | Class 2 | Orthopedic | No | 2026-01-09 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2026-01-09 |
| Template | HWT | Class 1 | Orthopedic | No | 2025-04-07 |
| Total Shoulder Arthroplasty System | QHQ | Class 2 | Orthopedic | No | 2024-02-29 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2024-02-29 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2026-04-23 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2026-04-23 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2020-01-24 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2020-01-24 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2022-09-02 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2026-01-09 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2022-02-07 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-02-14 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2021-07-02 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-12-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-02-04 |
Proprietary Names
Exactech® Alteon® HA Femoral Stem
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)