HARWOOD DESIGN, INC.

FDA Device Registration & Listing · Bristol, PA, US · Registration 3003761012

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
3003761012
FEI Number
3003761012
Entity Name
HARWOOD DESIGN, INC.
City/State/Country
Bristol, PA, US
Establishment Address
1507 Clyde Waite Drive, Bristol, PA 19007, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Harwood Design, Inc. (Owner Number: 10043110)
Owner / Operator Contact Address
1507 Clyde Waite Drive, Bristol, PA 19007, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TRIFORE CERVICAL PLATE SYSTEM TRANSOM CERVICAL PLATE SYSTEM LATIS CREO AMP Threaded Stabilization System ExcelsiusFlex Arthroplasty FORTIFY I EXCELSIUS Core Spine Pilling Pilling Laser Bronchoscopes CREO AMP Threaded Deformity Stabilization EXCELSIUS Core Spine TRUSS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2026-03-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2026-03-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-03-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-03-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-01-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-08
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-16
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-03-16
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2026-03-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-03-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-16
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2026-03-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-03-16
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2026-03-16
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2026-03-16
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2026-03-16
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-03-16
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2026-03-16
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2026-03-16
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2026-03-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-08
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2026-03-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-01-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-01-22
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2014-01-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-01-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-01-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-01-22
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-03-16
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-03-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-29
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-29
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2016-12-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-12-13
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 2013-01-30
GAD Retractor General, Plastic Surgery Class 1 878.4800 2013-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-12-13
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2013-01-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2016-12-13
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2026-03-16
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2026-03-16
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-03-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-03-16
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-29
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2016-03-17
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2016-03-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-03-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-16
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-16
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-03-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-29
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-03-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2026-03-13
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2026-03-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-03-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-03-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-04-08
DDS Prealbumin, Fitc, Antigen, Antiserum, Control Immunology Class 1 866.5060 2016-08-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-16
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2016-08-03
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2016-08-03
EOX Esophagoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4710 2016-06-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-03-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-03-16
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2013-01-30
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-01-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-29
PGM Growing Rod System Orthopedic Class 2 888.3070 2025-04-08
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2014-01-22
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2016-08-03
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2026-03-16
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2026-03-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-03-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-01-29
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-04-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-04-08
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-08
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2016-08-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-29
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2016-08-03
EQN Laryngoscope, Nasopharyngoscope Ear, Nose, Throat Class 2 874.4760 2016-06-21
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2016-08-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-04-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-04-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-16
JEK Forceps, Biopsy, Bronchoscope (Rigid) Ear, Nose, Throat Class 2 874.4680 2016-06-21
EOX Esophagoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4710 2016-06-21
EWY Mediastinoscope, Surgical Ear, Nose, Throat Class 2 874.4720 2016-06-21
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-29
HWJ Awl Orthopedic Class 1 888.4540 2013-01-30
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2013-01-30
EQH Source, Carrier, Fiberoptic Light Ear, Nose, Throat Class 1 874.4350 2013-01-30
KCD Bougie, Esophageal, Ent Ear, Nose, Throat Class 1 874.4420 2013-01-30
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-01-25
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-03-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-03-16
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2025-04-08
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 2016-08-03
FDG Retractor, Fiberoptic Gastroenterology, Urology Class 1 876.4530 2013-01-30
LLO Laser, Neodymium:Yag, Pulmonary Surgery Ear, Nose, Throat Class 2 874.4500 2021-08-31
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-03-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-03-13
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2013-01-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-13
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2016-08-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-03-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-03-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-13
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2026-03-13
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-03-13
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2026-03-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-13
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2026-03-13
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2013-01-30
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-29
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2016-06-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-16
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2026-03-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-03-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-03-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-29
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-03-16
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2013-01-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-29
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2016-12-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-12-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2016-12-13
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2013-01-29
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2016-06-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-29
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2013-01-29
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2013-01-29
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2013-01-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-29
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2016-08-03
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2016-06-21
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-03-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-03-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-03-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-13

Official Correspondent

Adam Cilli

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Harwood Design, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003761012. Last updated year: 2026. Please use registration number 3003761012 when referencing this establishment in official correspondence.
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