FDA Registration
Active
🇺🇸 United States
ARVATO USA LLC
Reg #: 3021008900
·
FEI: 3021008900
·
Expires 2026
Products
55
Proprietary Names
1
Establishment Types
1
Classifications
55
Registration Details
- Registration Name
- ARVATO USA LLC
- Registration Number
- 3021008900
- FEI Number
- 3021008900
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3303 E Holmes Rd
- City
- Memphis
- State
- TN
- ZIP
- 38118
- Country
- US
Regulatory Submissions
- 510(k) Number
- K083032
- PMA Number
- P040033
Owner / Operator
- Firm Name
- Arvato USA LLC
- Operator Number
- 10082727
- Address
- 3303 E Holmes Rd
- City
- Memphis
- State
- TN
- Postal Code
- 38118
- Country
- US
- Correspondent
- Raymundo Gutierrez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-10-19 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-10-19 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2021-10-18 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-10-19 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2021-10-18 |
| Mesh, Surgical, Acetabular, Hip, Prosthesis | JDJ | Class 2 | General, Plastic Surgery | No | 2021-10-19 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2021-09-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2021-09-23 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2021-10-19 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2021-10-18 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-10-18 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2021-10-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2021-09-23 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2021-10-19 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2021-10-19 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2021-10-19 |
| Washer, Bolt, Nut, Non-Spinal, Metallic | NDG | Class 2 | Orthopedic | No | 2021-10-19 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2021-10-19 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2021-10-19 |
| Cement Obturator | LZN | Class 2 | General, Plastic Surgery | No | 2021-10-19 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2021-09-23 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-10-19 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-09-23 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2021-10-19 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2021-10-19 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2021-09-23 |
| Software For Diagnosis/Treatment | OSN | Class 2 | Orthopedic | No | 2021-10-19 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2021-10-18 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2021-09-23 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2021-09-23 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2021-09-23 |
| Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | KRQ | Class 2 | Orthopedic | No | 2021-10-19 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2021-10-19 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2021-10-19 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2021-10-19 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2021-10-19 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2021-10-19 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2021-10-19 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2021-10-19 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2021-10-19 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2021-10-19 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2021-09-23 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2021-09-23 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2021-09-23 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2021-09-23 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2021-10-19 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | MBV | Class 2 | Orthopedic | No | 2021-10-19 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2021-10-19 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2021-09-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | NXT | Class 3 | Unknown | No | 2021-10-19 |
| System, X-Ray, Fluoroscopic, Non-Image-Intensified | JAB | Class 2 | Radiology | No | 2021-10-19 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2021-10-19 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2021-09-23 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2021-10-18 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | MRA | Class 3 | Unknown | No | 2021-10-19 |
Proprietary Names
Smith and Nephew
Establishment Types
Repack or Relabel Medical Device