DONSON MACHINE COMPANY

FDA Device Registration & Listing · ALSIP, IL, US · Registration 3004153896

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
3004153896
FEI Number
3004153896
Entity Name
DONSON MACHINE COMPANY
City/State/Country
ALSIP, IL, US
Establishment Address
12416 S KEDVALE AVE, ALSIP, IL 60803, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
DONSON MACHINE COMPANY (Owner Number: 9057685)
Owner / Operator Contact Address
12416 S KEDVALE AVE, --, Alsip, IL 60803, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RIO Partial Knee Application Instrumentation Modular Unipolar Santorini Epic Caspian, Mesa Mini, Denali Mini TAPERLOC COMPLETE MICROPLASTY STEM Chesapeake Lumbar Arcos Modular Hip System Augment Reamer Driver Augment Glenoid Check Guide Augment Reamer Zimmer Biomet Instrument Silverton Telluride Endoskeleton™ TL Advantim patellar endmill Advantim patellar template Endoskeleton™ TO Orthopedic Salvage System Instruments G7 Revision Acetabular System Endoskeleton™ TO Endoskeleton™ TA Comprehensive SRS Comprehensive Instruments Aleutian Guide, Surgical Instruments Range, Mesa, Denali, Natural Bridge Endoskeleton™ TC Endoskeleton™ TO Endoskeleton™ TT Comprehensive® Reverse Shoulder CD Horizon Spinal System Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented Persona Revision Knee System Range Small Stature, Mesa CoCr Wire, Nile PERSONA REVISION KNEE SYSTM GENERAL Endoskeleton™ TC Pyrenees, Blue Ridge ALPS Proximal Humerus Plating System Durango Range Pediatric Zimmer Biomet Reverse Shoulder Prosethesis Vail Orthopedic Salvage System Instruments Endoskeleton™ TT Endoskeleton TA TAPERLOC COMPLETE, SIZE 5 AND 6 Rosa Shoulder Cayman Thoracolumbar G7 Revision Acetabular System RIO Partial Knee Application Instrumentation TAPERLOC COMPLETE, SIZE 4MM & XR 123 Pyrenees COMPREHENSIVE REVERSE INST Orthopedic Salvage System Instruments Orthopedic Salvage System Instruments Comprehensive SRS Zimmer Nexel Total Elbow - Ulnar Bearing Tamp Zimmer Nexel Total Elbow - Trephine Stabilizer S25/6 Zimmer Nexel Total Elbow - Trephine Stabilizer S24 Persona Revision Knee System Affixus Tibial and Antegrade Femoral Nailing System Zimmer Trabecular Metal reverse shoulder system Off-Axis PSN Valgus Alignment Guide, W/UW RIO Partial Knee Application Instrumentation - 111734 RIO Partial Knee Application Instrumentation - 111120 Endoskeleton™ TT Endoskeleton™ TL PSN Valgus Alignment Guide, UW/UW PSN Valgus Alignment Guide, W/W PSN Valgus Alignment Guide, UW/W COMPREHENSIVE REVERSE INST Comprehensive Shoulder System ROSA® Stabilizer Tissue Deflector, 60mm ROSA® Pin Stabilizer, 60mm Zimmer Trabecular Metal reverse shoulder system

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2016-02-25
KXA Prosthesis, Hip, Femoral, Resurfacing Orthopedic Class 2 888.3400 2012-12-07
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-12-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-31
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-04-05
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2021-04-05
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-04-05
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-04-05
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2021-04-05
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2021-04-05
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2021-04-05
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-04-05
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2021-04-05
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-04-05
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-31
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-01-31
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2020-07-16
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2020-07-16
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2020-07-16
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2020-07-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2020-07-16
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2020-07-16
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2020-07-16
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-07-16
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2020-07-16
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2020-02-24
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-02-24
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2021-07-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-12-17
HXG Tamp Orthopedic Class 1 888.4540 2021-06-07
HWT Template Orthopedic Class 1 888.4800 2014-01-02
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2019-11-14
HTW Bit, Drill Orthopedic Class 1 888.4540 2026-01-29
HTE Elevator General, Plastic Surgery Class 1 878.4800 2021-06-07
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2022-01-05
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2020-01-07
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2020-01-07
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2020-01-07
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-01-07
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2019-12-19
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2019-12-19
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-31
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-01-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-31
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2020-01-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-31
HTF Curette General, Plastic Surgery Class 1 878.4800 2021-06-07
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-05-13
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2020-05-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-11-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-11-27
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2021-09-01
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2021-09-01
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2021-09-01
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-09-01
PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Orthopedic Class 2 888.3310 2021-09-01
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2021-09-01
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-09-01
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-09-01
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2018-10-29
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2018-10-29
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-10-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-31
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2013-01-31
HXX Screwdriver Orthopedic Class 1 888.4540 2019-03-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-03-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-01-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2012-12-17
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-12-17
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2012-12-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-31
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-31
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-01-30
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2018-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-01-30
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2023-01-11
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2023-01-11
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2026-04-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-04-22
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2026-04-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2026-04-22
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2026-04-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-12-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-17
HWA Impactor Orthopedic Class 1 888.4540 2019-11-14
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2021-04-05
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-04-05
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2021-04-05
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2021-04-05
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-04-05
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-04-05
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-04-05
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2021-04-05
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2021-04-05
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-04-05
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2021-04-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-02-29
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-02-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-31
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-02-10
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2026-02-10
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-02-10
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2026-02-10
PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Orthopedic Class 2 888.3310 2026-02-10
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2026-02-10
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2026-02-10
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2016-02-25
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-04-05
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-04-05
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2021-04-05
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2021-04-05
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2021-04-05
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-04-05
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-04-05
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-04-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-31
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-03-16
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-03-16
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2022-03-16
HTQ Broach Orthopedic Class 1 888.4540 2019-11-14
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2019-11-14
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2019-11-14
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2019-11-14
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2020-01-07
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2018-06-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2019-11-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2019-11-19
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2019-11-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-10-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-10-07
HWX Tap, Bone Orthopedic Class 1 888.4540 2018-11-06
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2012-12-07
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2026-02-11
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2026-02-11
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-02-11
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-11-19
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-03-16
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-03-16
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-03-24
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-03-24
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2022-03-24
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-03-24
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-11-26
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2012-12-07
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2012-12-07
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2012-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DONSON MACHINE COMPANY
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
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
K041888 Signus Medizintechnik GmbH CURVED PEEK TETRIS SPINAL IMPLANT 2004-08-10
K211892 Arftx Medical, LLC ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) 2022-10-06
K070082 Vertebration,Inc XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY 2007-04-20
K051027 Surgicraft , Ltd. STALIF TT 2005-06-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

Similar Registrations

Registration Number Establishment Name Location
3002743211 NORTHERN DIGITAL, INC. WATERLOO Ontario, CA
3016050940 Olive Branch Distribution Center Olive Branch, MS, US
3020983478 ORTHOKEY ITALIA SRL Firenze, IT
3014725904 Medtronic Medical Costa Rica S.R.L. Coyol Alajuela, CR
3018405359 A7 INTEGRATION Granby Quebec, CA
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004153896. Last updated year: 2026. Please use registration number 3004153896 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.