Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038195984

FEI Number

3038195984

Entity Name

BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.

City/State/Country

Beijing, CN

Establishment Address

No.50, Mafang West Industry Zone, Pinggu District, Beijing, China., Beijing 101204, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Beijing Fule Science & Technology Development Co., Ltd (Owner Number: 10093069)

Owner / Operator Contact Address

No.50, Mafang West Industry Zone, Pinggu District, Beijing, China., Beijing, CN-BJ 101204, 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
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2025-03-26
HTO	Reamer	Orthopedic	Class 1	888.4540	2025-03-26
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2025-03-26
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2025-03-26
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2025-03-26
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2025-03-26
HXW	Bender	Orthopedic	Class 1	888.4540	2025-03-26
HTX	Rongeur	Orthopedic	Class 1	888.4540	2025-03-26
HXC	Wrench	Orthopedic	Class 1	888.4540	2025-03-26
HWK	Trephine	Orthopedic	Class 1	888.4540	2025-03-26
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-03-26
HWT	Template	Orthopedic	Class 1	888.4800	2025-03-26
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2025-03-26
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2025-03-26
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2025-03-26
HWJ	Awl	Orthopedic	Class 1	888.4540	2025-03-26
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2025-03-26
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-03-26
KIL	Positioner, Socket	Orthopedic	Class 1	888.4540	2025-03-26
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-03-26
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-03-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-03-26
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-03-26
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2025-03-26
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-03-26

Official Correspondent

Miao Liu

US Agent Details

Wei ZHANG Business: 3dstocking Inc Email: ge@3dstocking.com Phone: (772) 9996108

Related Public Records

Same Entity

Beijing Fule Science & Technology Development 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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

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-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038195984. Last updated year: 2026. Please use registration number 3038195984 when referencing this establishment in official correspondence.