Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011423165

FEI Number

3011423165

Entity Name

KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Xi'an Shaanxi, CN

Establishment Address

No.1451, 1st Biyuan Road, High-tech District,, Xi'an Shaanxi 710065, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Kontour (Xi'an) Medical Technology Co., Ltd. (Owner Number: 10062728)

Owner / Operator Contact Address

No.1451, 1st Biyuan Road, High-tech District,, Xi'an, CN-SN 710065, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Modified Sterile Plate and Screw Configuration Bioplate Rigid Fixation System Bioplate Rigid Fixation System PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) Modified Screw Design Disposable Screwdriver Blade Bioplate Rigid Fixation System Bioplate Rigid Fixation System Modification to Bioplate Rigid Fixation System Bioplate Rigid Fixation System BIOMESH Bioplate Rigid Fixation System Sterile Plate and Screw Configuration Titanuim Fixation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEY	Plate, Bone	Dental	Class 2	872.4760	2020-03-12
JEY	Plate, Bone	Dental	Class 2	872.4760	2020-03-04
JEY	Plate, Bone	Dental	Class 2	872.4760	2020-03-04
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2022-11-15
JEY	Plate, Bone	Dental	Class 2	872.4760	2020-03-11
GXL	Screwdriver, Skullplate	Neurology	Class 1	882.4900	2024-02-20
JEY	Plate, Bone	Dental	Class 2	872.4760	2020-03-04
JEY	Plate, Bone	Dental	Class 2	872.4760	2020-03-04
JEY	Plate, Bone	Dental	Class 2	872.4760	2020-03-12
JEY	Plate, Bone	Dental	Class 2	872.4760	2020-03-04
JEY	Plate, Bone	Dental	Class 2	872.4760	2024-09-04
JEY	Plate, Bone	Dental	Class 2	872.4760	2020-03-04
JEY	Plate, Bone	Dental	Class 2	872.4760	2020-03-04
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2020-03-04

Official Correspondent

rongrong cong

US Agent Details

Yoon Choi Email: YChoi@bioplate.com Phone: (424) 2581814

Related Public Records

Same Entity

Kontour (Xi'an) Medical 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
K172572	Stryker	Stryker Upper-Face AXS screws and Mid-Face AXS screws	2017-10-31
K121589	Biomet Microfixation	BIOMET MICROFIXATION FACIAL PLATING SYSTEM	2012-09-21
K984230	Osteogenics Biomedical, Inc.	OSTEO-MESH TM-300	1999-02-04
K021618	Osteomed Corp.	OSA RIGID INTERNAL FIXATION SYSTEM	2002-08-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2007	Bioplate Inc	2	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45

Similar Registrations

Registration Number	Establishment Name	Location
3017734069	REOSS GMBH	Filderstadt Baden-Wurttemberg, DE
1032347	BIOMET MICROFIXATION	Jacksonville, FL, US
2029275	Sterigenics U.S., LLC	Corona, CA, US
3006017180	BBF STERILISATIONSSERVICE GMBH	Kernen Baden-Wurttemberg, DE
3008812560	Synthes (USA) Products LLC	West Chester, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011423165. Last updated year: 2026. Please use registration number 3011423165 when referencing this establishment in official correspondence.