Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005323511

FEI Number

3005323511

Entity Name

XIAN AIRFOIL TECHNOLOGY CO., LTD.

City/State/Country

Xian Shaanxi, CN

Establishment Address

50Th Building, East hong Qi Road, Xujiawan, Beijiao, Xian Shaanxi 710021, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Xian Airfoil Technology Co., Ltd. (Owner Number: 10043573)

Owner / Operator Contact Address

50Th Building, East hong Qi Road, Xu Jiawan, Beijiao, Xi'an, CN-SN 710021, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

67210535 Accolade II Hip Stem 67210330 67200737 Accolade II Hip Forging Stryker 67210635 67210435 67200330 67200435 67200535 67210737 67200635

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2013-02-28
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-02-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-02-28
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-02-28
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2013-02-28
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-02-28
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-02-28
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-02-28

Official Correspondent

Zhang Hong

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Xian Airfoil Technology 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
K042344	Aesculap, Inc.	EXCIA TOTAL HIP SYSTEM	2005-03-16
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
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10
K932222	Dow Corning Wright	SLT FEMORAL HEAD	1994-05-27

Similar Registrations

Registration Number	Establishment Name	Location
3005061536	SYMMETRY MEDICAL MANUFACTURING INC	CLAYPOOL, IN, US
3007923096	Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, CN
3006801265	Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, CN
2134285	RIVERSIDE MACHINE & ENGINEERING, INC.	Eau Claire, WI, US
3043543260	FERRY MACHINE CORPORATION	Oakland, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005323511. Last updated year: 2026. Please use registration number 3005323511 when referencing this establishment in official correspondence.