Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043105162

FEI Number

3043105162

Entity Name

CHONGQING ORTHOPAEDIC TECHNOLOGY INSTITUTE CO., LTD.

City/State/Country

Chongqing, CN

Establishment Address

1st and 2nd Floor Industrial Factory & 1st floor Eastside of Supporting Workshop in Building 11, No.28 Gaoxin Avenue, Jinfeng Town, High-tech Zone, Chongqing 400039, People's Republic of China, Chongqing 101149, CN

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Chongqing Orthopaedic Technology Institute Co., Ltd. (Owner Number: 10094529)

Owner / Operator Contact Address

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LexTOME Neo MIS Acetabular Reamer E1040 LexTOME Neo MIS Acetabular Reamer RE1040 LexTOME Neo Acetabular Reamer RE1039 LexTOME Neo Acetabular Reamer E1039

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTO	Reamer	Orthopedic	Class 1	888.4540	2026-01-07

Official Correspondent

Yinong Zhang

US Agent Details

Takahiro Haruyama Business: GLOBIZZ CORPORATION Email: register@globizz.net Phone: (310) 5383833

Related Public Records

Same Entity

Chongqing Orthopaedic Technology Institute Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043105162. Last updated year: 2026. Please use registration number 3043105162 when referencing this establishment in official correspondence.