Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018269629

FEI Number

3018269629

Entity Name

AIKE (SHANGHAI) MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

Room F201, Floor2, Building 6, No.125, LongPan Road, Malu Town, Jiading District, 201801, Shanghai, China, Shanghai 201801, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Aike (Shanghai) Medical Instrument Co., Ltd. (Owner Number: 10080234)

Owner / Operator Contact Address

B320, B321, B322, B323, No. 1128, South Huicheng Road, Jiading Industrial District, Shanghai, CN-SH 201801, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200491

PMA Number

N/A

All Registered Proprietary Names

BFIX INSTRUMENTS ZS6 Bfix® Orthopedic External Fixator Systems ZS7

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-03-27
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-01-20
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2021-01-20

Official Correspondent

Hao Wang

US Agent Details

Leeyeo KEE Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Aike (Shanghai) Medical Instrument 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
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20
K223112	Smith & Nephew, Inc.	MAVERICK Mini External Fixation System	2022-12-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3018033084	NEXT GENERATION TOOLING INC	Akron, OH, US
3038207124	NATIVE ORTHOPAEDICS	Providence, RI, US
3027516563	STAR SPORTS MEDICINE CO., LTD.	Beijing, CN
3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018269629. Last updated year: 2026. Please use registration number 3018269629 when referencing this establishment in official correspondence.