SUZHOU ENDOPHIX CO., LTD.

FDA Device Registration & Listing · Suzhou Jiangsu, CN · Registration 3030514683

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
3030514683
FEI Number
3030514683
Entity Name
SUZHOU ENDOPHIX CO., LTD.
City/State/Country
Suzhou Jiangsu, CN
Establishment Address
Room 202, Factory No.3, Lane 151, Fengli Road, SIP, 215000 Suzhou, Jiangsu Province, P.R. CHINA, Suzhou Jiangsu 215000, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Suzhou Endophix Co., Ltd. (Owner Number: 10089613)
Owner / Operator Contact Address
Lane 151, Fengli Road, SIP, 215000 Suzhou, Jiangsu Province, P.R. CHINA, Suzhou, CN-JS 215000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Knee Surgery Instrument, Shoulder Surgery Instrument Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath Arthroscopic cannula Drill & Guide, Knee Surgery Instrument, Shoulder Surgery Instrument Orthopedic Passer Instrument, Shoulder Surgery Instrument Knee Surgery Instrument Knee Surgery Instrument, Shoulder Surgery Instrument Orthopedic Surgical Instrument, Shoulder Surgery Instrument Single-use Shaver Blade Knee Surgery Instrument, Shoulder Surgery Instrument Knee Surgery Instrument Knee Surgery Instrument, Shoulder Surgery Instrument Graft Preparation Platform Set, Knee Surgery Instrument, Shoulder Surgery Instrument, Tissue Suture Passer Rotator Cuff Repair Instrument, Shoulder Surgery Instrument Knee Surgery Instrument, Shoulder Surgery Instrument

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KIL Positioner, Socket Orthopedic Class 1 888.4540 2023-12-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-12-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-12-22
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2023-12-22
HTW Bit, Drill Orthopedic Class 1 888.4540 2023-12-22
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2023-12-22
HXX Screwdriver Orthopedic Class 1 888.4540 2023-12-22
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2023-12-22
HTD Forceps General, Plastic Surgery Class 1 878.4800 2023-12-22
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2023-12-22
HXB Probe Orthopedic Class 1 888.4540 2023-12-22
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2023-12-22
HTP File Orthopedic Class 1 888.4540 2023-12-22
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-12-22
HWJ Awl Orthopedic Class 1 888.4540 2023-12-22

Official Correspondent

Bin Wu

US Agent Details

Rachael Wise Email: Rachael.Wise@ortho.microport.com Phone: (901) 8674771

Related Public Records

Same Entity

Suzhou Endophix 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 3030514683. Last updated year: 2026. Please use registration number 3030514683 when referencing this establishment in official correspondence.
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