ARVATO USA LLC

FDA Device Registration & Listing · Memphis, TN, US · Registration 3021008900

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021008900
FEI Number
3021008900
Entity Name
ARVATO USA LLC
City/State/Country
Memphis, TN, US
Establishment Address
3303 E Holmes Rd, Memphis, TN 38118, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Arvato USA LLC (Owner Number: 10082727)
Owner / Operator Contact Address
3303 E Holmes Rd, Memphis, TN 38118, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P040033

All Registered Proprietary Names

Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew Smith and Nephew

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2021-10-18
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis General, Plastic Surgery Class 2 878.3300 2021-10-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-09-23
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-09-23
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-09-23
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-18
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-18
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2021-10-19
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2021-10-18
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-18
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-10-18
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2021-10-18
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-10-19
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2021-09-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-09-23
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-09-23
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2021-10-19
NDG Washer, Bolt, Nut, Non-Spinal, Metallic Orthopedic Class 2 888.3030 2021-10-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-09-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-10-19
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2021-10-19
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2021-10-19
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-19
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-18
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-18
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-10-18
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-19
JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis General, Plastic Surgery Class 2 878.3300 2021-10-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2021-10-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-09-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-09-23
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-10-18
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-19
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2021-10-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-10-19
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2021-10-19
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-10-19
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-19
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-09-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-10-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-10-18
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-19
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2021-10-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-10-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-09-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-10-18
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-18
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-09-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-09-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-09-23
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-09-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-19
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2021-09-23
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-09-23
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2021-09-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2021-10-19
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2021-10-19
KRQ Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3550 2021-10-19
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-10-19
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2021-10-19
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2021-10-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-09-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2021-10-19
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-19
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2021-10-19
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2021-10-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-19
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-10-19
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2021-10-19
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2021-10-18
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-10-19
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2021-10-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-19
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2021-10-18
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-10-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-18
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-10-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-18
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-18
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-09-23
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2021-10-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-19
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2021-10-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2021-09-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-09-23
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-09-23
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-09-23
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2021-09-23
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-09-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-09-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-09-23
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2021-10-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-10-19
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-19
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2021-10-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-10-19
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2021-10-19
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2021-10-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2021-09-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-10-19
OOG Knee Arthroplasty Implantation System Orthopedic Class 2 888.3560 2021-10-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-09-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-18
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2021-09-23
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2021-10-18
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-18
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-18
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-09-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball Orthopedic Class 2 888.3360 2021-10-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-10-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-09-23
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2021-10-18
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-09-23
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2021-10-18
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-19
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2021-10-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-10-18
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2021-10-18
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-09-23
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2021-09-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-09-23
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-09-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-18
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-10-18
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-09-23
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-09-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-10-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-10-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-10-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-10-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-10-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-09-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-18
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-09-23
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-09-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-19
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-10-19
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2021-10-19
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-18
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2021-10-18
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2021-10-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-19
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2021-10-19
MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-19
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-09-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2021-10-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-10-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-09-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-10-19
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2021-09-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-09-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-19
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-09-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-10-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-09-23
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-10-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-10-19
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2021-10-19
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2021-10-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-10-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-10-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-10-19
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2021-10-19
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-10-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-10-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-10-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-09-23
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2021-10-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-23
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2021-10-19
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2021-09-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-10-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-10-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-09-23
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-09-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-09-23
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-09-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-10-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-10-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-10-19
NXT Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing Unknown Class 3 N/A 2021-10-19

Official Correspondent

Raymundo Gutierrez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Arvato USA LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

Similar Registrations

Registration Number Establishment Name Location
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3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
8043862 AAP IMPLANTATE AG BERLIN, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021008900. Last updated year: 2026. Please use registration number 3021008900 when referencing this establishment in official correspondence.
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