Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013875765

FEI Number

3013875765

Entity Name

XINHUA HEALTHCARE INDUSTRY CO.,LIMITED

City/State/Country

Zibo Shandong, CN

Establishment Address

No.2999 Zunxian Road, Zibo New & Hi-tech Zone, Zibo Shandong 255086, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Xinhua Healthcare Industry Co.,Limited (Owner Number: 10055614)

Owner / Operator Contact Address

No.2999 Zunxian Road, Zibo New & Hi-tech Zone, Zibo, CN-SD 255086, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Depth Gauge Bone Measurer Gauge Liner Extractor Coxae Chisel Chisel Bone-chisel Plate Cutter Rod Cutter Wire Plier Cutter Uterine Curette Bone Needle Bone marrow agent Screwdriver Orthopedic screwdriver Acetabular bone rasp Medullary space rasp Bone file Bone lever Nerve Dissector Periosteal Elevator Micro Dissector Plate Bender Rod Bender Bar Bender Bone curet Awl Screw Tap Tip Screw Clamp Reduction forceps of orthopaedics Holder Bone Clamp Plate Holder Hook Holder Three-jaw reduction forceps Reduction forceps of pelvic Rod Holder Forceps Compressing Forceps Rod Clamp Break Off Iron Drill Bit Counter Drill Hook Trail Cavum Medullary Enlarging Drill Drill guide Remover Of Broken Bone Screws Screw Holding Forceps Easyout Extractor Trephine Screw Driver Flexible Reamer Shaft Bone Reamer Bone Locating Plate Thighbone Marrow Cavity Alignment Hand Shank Cover Quick-change Handle Knee unbending interval gasket Goniometer Cutter and Bender Cutter Bone Rongeur Screw Holder Forceps Holding Forceps Adjustable fixed support Kerrison Punch Laminectomy Rongeur wire saw gride Bone Drill gunsight Wire Guide Ti-Cage Cutting Scissors Pin Cutting Scissors Wire Cutting Scissors Sliding Hammer Bone Mallet Impactor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2017-08-23
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2017-08-23
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2017-08-23
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2017-08-23
HXB	Probe	Orthopedic	Class 1	888.4540	2017-08-23
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2017-08-23
HTP	File	Orthopedic	Class 1	888.4540	2017-08-23
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-08-23
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2017-08-23
HXW	Bender	Orthopedic	Class 1	888.4540	2017-08-23
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2017-08-23
HWJ	Awl	Orthopedic	Class 1	888.4540	2017-08-23
HTX	Rongeur	Orthopedic	Class 1	888.4540	2017-08-23
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2017-08-23
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2017-08-23
HWB	Extractor	Orthopedic	Class 1	888.4540	2017-08-23
HXC	Wrench	Orthopedic	Class 1	888.4540	2017-08-23
HTO	Reamer	Orthopedic	Class 1	888.4540	2017-08-23
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-08-23
KQW	Goniometer, Nonpowered	Orthopedic	Class 1	888.1520	2017-08-23
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-08-23
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-08-23
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-08-23
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2017-08-23
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-08-23
HWA	Impactor	Orthopedic	Class 1	888.4540	2017-08-23

Official Correspondent

Hong Kou

US Agent Details

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

Related Public Records

Same Entity

Xinhua Healthcare Industry Co.,Limited

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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013875765. Last updated year: 2026. Please use registration number 3013875765 when referencing this establishment in official correspondence.