Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012130008

FEI Number

3012130008

Entity Name

MicroPort Orthopedics Global Supply Center Limited

City/State/Country

Shanghai, CN

Establishment Address

Room 202 ,Building 6,No.77, Fu Te West 3 Rd., China (Shanghai) Pilot Free Trade Zone,, Shanghai 200131, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

MicroPort Orthopedics Global Supply Center Limited (Owner Number: 10079974)

Owner / Operator Contact Address

Room 202 ,Building 6,No.77, Fu Te West 3 Rd. China (Shanghai) Pilot Free Trade Zone, Shanghai Shanghai, Shanghai, CN-SH 201203, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dynasty Dual Mobility System Instrumentation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWT	Template	Orthopedic	Class 1	888.4800	2021-01-06
HXW	Bender	Orthopedic	Class 1	888.4540	2021-01-06
HTQ	Broach	Orthopedic	Class 1	888.4540	2021-01-06
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2021-01-06
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2021-01-06
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	2021-01-06
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2021-01-06
HWW	Countersink	Orthopedic	Class 1	888.4540	2021-01-06
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2021-01-06
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2021-01-06
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-08-01
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2025-08-01
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-08-01
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-08-01
HXG	Tamp	Orthopedic	Class 1	888.4540	2021-01-06
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2021-01-06
HTX	Rongeur	Orthopedic	Class 1	888.4540	2021-01-06
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2021-01-06
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2021-01-06
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-01-06
FNS	Ring Cutter	General Hospital	Class 1	880.6200	2021-01-06
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2021-01-06
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2021-01-06
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2021-01-06
HWO	Skid, Bone	Orthopedic	Class 1	888.4540	2021-01-06
HXN	Applier, Cerclage	Orthopedic	Class 1	888.4540	2021-01-06
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2021-01-06
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2021-01-06
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2021-01-06
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2021-01-06
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2021-01-06
HWJ	Awl	Orthopedic	Class 1	888.4540	2021-01-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-01-06
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2021-01-06
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2021-01-06
HWP	Punch, Femoral Neck	Orthopedic	Class 1	888.4540	2021-01-06
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-01-06
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2021-01-06
HXB	Probe	Orthopedic	Class 1	888.4540	2021-01-06
KTZ	Caliper	Orthopedic	Class 1	888.4150	2021-01-06
HTP	File	Orthopedic	Class 1	888.4540	2021-01-06
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2021-01-06
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-01-06
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2021-01-06
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2024-04-06
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-04-06
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-04-06
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-04-06
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-04-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-04-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-04-06
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-01-06
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-01-06
HTO	Reamer	Orthopedic	Class 1	888.4540	2021-01-06
HWA	Impactor	Orthopedic	Class 1	888.4540	2021-01-06
HWB	Extractor	Orthopedic	Class 1	888.4540	2021-01-06
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2021-01-06
HWK	Trephine	Orthopedic	Class 1	888.4540	2021-01-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-04-06
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2024-04-06
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-04-06
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-01-06
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2021-01-06
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2021-01-06
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-01-06
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2021-01-06
HXC	Wrench	Orthopedic	Class 1	888.4540	2021-01-06
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2021-01-06
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2021-01-06
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2021-01-06

Official Correspondent

Chufan Zhang

US Agent Details

Rachael Wise Email: Rachael.Wise@Ortho.Microport.Com Phone: (901) 8674771

Related Public Records

Same Entity

MicroPort Orthopedics Global Supply Center Limited

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
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K823482	Intermedics Orthopedics	101 UNIVERSAL ENDOPROSTHESIS	1983-02-07
K201660	Kyocera Medical Technologies, Inc.	KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System	2020-07-16
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
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
3030638495	WAREMA KUNSTSTOFFTECHNIK UND MASCHINENBAU GMBH	Marktheidenfeld Bavaria, DE
1835305	Masterbilt Incorporated	South Bend, IN, US
3009631939	RED STAR CONTRACT MANUFACTURING INC.	Larwill, IN, US
9610612	AESCULAP AG	TUTTLINGEN, DONAU Baden-Wurttemberg, DE
3015383864	S.M.A.I.O	SAINT-PRIEST Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012130008. Last updated year: 2026. Please use registration number 3012130008 when referencing this establishment in official correspondence.