ZIBO DANTE CO, LTD

FDA Device Registration & Listing · Zibo City Shandong, CN · Registration 3012711663

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
3012711663
FEI Number
3012711663
Entity Name
ZIBO DANTE CO, LTD
City/State/Country
Zibo City Shandong, CN
Establishment Address
No. 206 Industry Yi Road, Huantai, Zibo City Shandong 256400, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Zibo Dante Co, LTD (Owner Number: 10058316)
Owner / Operator Contact Address
No. 206 Industry Yi Road, Huantai, Zibo City, CN-SD 256400, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Simpact ARX Kinetic Sentry Plateau-C Nautilus/Avatar ProLift Wedge Forefoot Screw Neo ProLift Lateral Fixated ProLift Lateral Instruments Pro Lift Plateau Instruments Solstice Instruments Lynx ProLift Micro Plateau Kinetic-SL Gruve Suction Tube Aileron Manual Surgical Instruments Plateau-C Instruments External Fixation ARx Aileron Neo ARx Arx Illiac Dyna-Link Ti Solstice Centerline Modular Pro-Link Ultrasonic Dental Tip Solstice OCT Instruments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-02-07
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2025-02-07
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-01-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-02-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-02-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-02-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-02-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-02-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-02-06
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-02-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-05-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-02-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-02-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-02-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-09-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-01-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-04-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-04-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-02-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-02-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-02-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-05-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-02-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-02-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-02-06
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2019-04-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-02-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-02-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-02-14
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2018-08-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-04-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-01-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-02-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-02-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-02-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-02-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-02-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-01-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-02-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-02-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-02-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-02-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-04-12
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-04-12
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-02-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-02-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-02-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-01-17
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2025-08-21
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-04-19

Official Correspondent

Angela Batker

US Agent Details

Angela Batker Email: abatker@lifespine.com Phone: (847) 8846117

Related Public Records

Same Entity

Zibo Dante Co, LTD
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012711663. Last updated year: 2026. Please use registration number 3012711663 when referencing this establishment in official correspondence.
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