Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014662844

FEI Number

3014662844

Entity Name

SUZHOU MICROPORT ORTHORECON CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Building 2 and 3,N0.151,Fengli Street,Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone Suzhou District, Suzhou Jiangsu 215000, CN

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Suzhou MicroPort OrthoRecon Co., Ltd. (Owner Number: 10060911)

Owner / Operator Contact Address

Building 2 and 3,N0.151,Fengli Street,Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone Suzhou District, Suzhou, CN-JS 215000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2019-07-11
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2019-07-11
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-07-11
HTO	Reamer	Orthopedic	Class 1	888.4540	2024-08-01
KTZ	Caliper	Orthopedic	Class 1	888.4150	2019-07-11
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-08-01
HXB	Probe	Orthopedic	Class 1	888.4540	2019-07-11
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2019-07-11
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2024-08-01
KIL	Positioner, Socket	Orthopedic	Class 1	888.4540	2019-07-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-07-11
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2019-07-11
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-08-01
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2024-08-01
HTQ	Broach	Orthopedic	Class 1	888.4540	2024-08-01
HWT	Template	Orthopedic	Class 1	888.4800	2019-07-11
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2019-07-11
HWB	Extractor	Orthopedic	Class 1	888.4540	2019-07-11
HWA	Impactor	Orthopedic	Class 1	888.4540	2019-07-11

Official Correspondent

YuJian Mao

US Agent Details

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

Related Public Records

Same Entity

Suzhou MicroPort OrthoRecon 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014662844. Last updated year: 2026. Please use registration number 3014662844 when referencing this establishment in official correspondence.