SUZHOU AND SCIENCE & TECHNOLOGY DEVELOPMENT CORP.

FDA Device Registration & Listing · Zhangjiagang Jiangsu, CN · Registration 3015356625

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
3015356625
FEI Number
3015356625
Entity Name
SUZHOU AND SCIENCE & TECHNOLOGY DEVELOPMENT CORP.
City/State/Country
Zhangjiagang Jiangsu, CN
Establishment Address
No.2, Ansheng Road Hexing, Jinfeng Town, Zhangjiagang Jiangsu 215625, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Suzhou AND Science & Technology Development Corp. (Owner Number: 10082136)
Owner / Operator Contact Address
No.2, Ansheng Road Hexing, Jinfeng Town, Zhangjiagang, CN-JS 215625, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Polylock Plating System HammerTech Fixation System Trial Sizers

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-10-21
HWT Template Orthopedic Class 1 888.4800 2026-05-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-05-09

Official Correspondent

Zhu Tracy

US Agent Details

Hui Hong Business: Abmed Medical Technology Inc Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Suzhou AND Science & Technology Development Corp.
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
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
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.

Similar Registrations

Registration Number Establishment Name Location
3013843055 BEIJING AK MEDICAL CO, LTD Changping District Beijing, CN
3022777867 FIXIER S.A. DE C.V. Doctor Mora Guanajuato, MX
3017209758 NEBULA SURGICAL PRIVATE LIMITED Rajkot Gujarat, IN
3017609305 PRIMEMED INC. Sungnam-city Gyeonggi, KR
3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015356625. Last updated year: 2026. Please use registration number 3015356625 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.