Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011534620

FEI Number

3011534620

Entity Name

TURNXON PRECISION CO., LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Tangjiao Industry Park Chashan Town, Dongguan Guangdong 523393, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Turnxon Precision Co., Ltd (Owner Number: 10048717)

Owner / Operator Contact Address

Tangjiao Industry Park Chashan Town, Dongguan, CN-GD 523393, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 42-5399-501-00 Orthopedic Manual Surgical Instrument Orthopedic Manual Surgical Instrument 42-5399-502-00 Orthopedic Manual Surgical Instrument 00-8790-503-10 Orthopedic Manual Surgical Instrument ORTHOPEDIC MANUAL SURGICAL INSTRUMENT MALLEABLE TUNNELER, SINGLE BARB, 8 FR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Tunneler, Power CVC Tunneler, Power CVC, 4 Barb TUNNELER, POWERCVC, 4 BARB, 64 DIA. Tunneler, Power CVC TUNNELER, BLUNT, BARBED. MALLEABLE TUNNELER, SINGLE BARB, 8 FR MALLEABLE HEMOSPLIT TUNNELER I Tunneler, Power CVC, 4 Barb MALLEABLE HEMOSPLIT TUNNELER II Tunneler Assembly MALLEABLE HEMOSPLIT TUNNELER II 42-5399-018-14 PSN CEM TIB DRILL BIT 14X+30MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT MALLEABLE HEMOSPLIT TUNNELER II Tunneler, Malleable, .125 inch x 8 MALLEABLE TUNNELER, SINGLE BARB, 8 FR Tunneler, Aspira II MALLEABLE TUNNELER, SINGLE BARB, 8 FR Tunneler, Power CVC, 4 Barb MALLEABLE TUNNELER, SINGLE BARB, 8 FR 00-5901-090-00 2 DEG VALGUS RESECTION GUIDE 00-5901-090-01 2 DEG VARUS RESECTION GUIDE 00-5977-014-00 NEXGEN CEMENTED ST DRILL GDE MALLEABLE TUNNELER, SINGLE BARB, 8 FR MALLEABLE TUNNELER, SINGLE BARB, 8 FR MALLEABLE HEMOSPLIT TUNNELER II TUNNELER MALLEABLE GLIDEPATH TUNNELER AND SHEATH PRISTINE CATHETER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-02-29
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2016-02-29
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2016-02-29
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-02-16
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-02-29
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2018-01-13
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2016-02-29
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2018-01-12
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2018-01-12
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2018-01-30
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2018-01-13
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2018-01-30
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2018-01-12
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2018-01-30
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2018-01-30
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2026-06-07
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2016-02-29
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2018-01-30
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2018-01-30
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2018-01-13
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2018-01-13
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2018-01-13
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2018-01-12
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2018-01-13
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-06-07
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2018-01-13
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2018-01-13
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2018-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Turnxon Precision 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
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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8010379	DEPUY INTL., LTD.	LEEDS, GB
3007751820	ALVI Expo	Sialkot Punjab, PK
8010257	HERMANN MEDIZINTECHNIK GMBH	FRIDINGEN Baden-Wurttemberg, DE
3012226300	AVILIGN MEDICAL	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011534620. Last updated year: 2026. Please use registration number 3011534620 when referencing this establishment in official correspondence.