Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008791302

FEI Number

3008791302

Entity Name

LX PRECISION SHANGHAI CO LTD

City/State/Country

Shanghai, CN

Establishment Address

No.8, Lane 88, Yuanshan Rd., Minhang Dist., Shanghai 201108, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

LX PRECISION SHANGHAI CO LTD (Owner Number: 10034962)

Owner / Operator Contact Address

No.8 & 5, Lane 88, Yuanshan Rd., Minhang Dist., Shanghai, CN-SH 201108, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Biomet 3i Abutment Retaining Screws ACE CANNULATED CORTICAL BONE SCREW Biomet Lumbar Plate System Zimmer Biomet RAPIDFIRE SELF DRILLING SCREWS Neuro System 1.5mm System 1mm System 2mm System CMF System FBI® OptiLock® Periarticular Plating System TraumaOne System EBI® Periarticular Plating System ACE CANCELLOUS BONE SCREW EBI® OptiLock Upper Extremity Plating System EBI VueLockTM Anterior Cervical Plate System BIOMET 3i Dental Abutments EBI DFS® Joint Fixator Zimmer Biomet 2X9MM SD IMF SCREW 2X11MM SD IMF SCREW 2X7MM SD IMF SCREW 2X5MM SD IMF SCREW LORENZ SELF DRILLING SCREWS TRAUMA INTERNAL FIXATION SYSTEMS Biomet Headless Compression and Twist-off Screws BioDrive® Cannulated Screw System Zimmer Biomet Biomet® Tibial Locking Nail System EBI Anterior Cervical Plate System Zimmer Biomet Smith & Nephe Bone Plate System Biomet Microfixation OmniMax MMF System Cann Cort Bone Screw C-Tek® MaxAnTM Anterior Cervical Plate System Zimmer Biomet Biomet Headless Compression and Twist-off Screws 2X9MM T1 SD IMF SCREW 2X15MM IMF SCREW 2 X 13MM IMF SCREW 2X11MM T1 SD IMF SCREW 2X7MM T1 SD IMF SCREW BIOMET 3i Dental Abutments Biomet® Femoral Locking Nail System EBI® Distal Radius Plating System Affixus® Natural Nail® System Humeral Nail 3MM BIOMET CANNULATED SCREW SYSTEM EBI® XFIX® Vision® Fixation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2025-06-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-11-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-02-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-09-09
FMS	Bed, Pediatric Open Hospital	General Hospital	Class 2	880.5140	2023-11-24
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2011-01-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-11-23
JDO	Device, Fixation, Proximal Femoral, Implant	Orthopedic	Class 2	888.3030	2024-11-05
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2024-11-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-05
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2016-09-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-08-22
JEY	Plate, Bone	Dental	Class 2	872.4760	2019-07-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-05-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-11-23
JEY	Plate, Bone	Dental	Class 2	872.4760	2019-07-01
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2025-06-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-11-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-01-20
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-11-05
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-11-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-09-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-01-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-11-23
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2011-06-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-11-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-09-22
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2011-06-13
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2016-09-09
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-04-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-11-17
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2024-11-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-08-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-11-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-05-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-05
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2016-09-09
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2011-06-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-10-31
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-09-23
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2011-06-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-09-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-05
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2019-08-22
JEY	Plate, Bone	Dental	Class 2	872.4760	2019-08-22
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-05
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-11-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-08-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2011-01-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-09-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-11-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-11-23
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2018-04-13
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2011-01-25
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-05
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2011-06-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-01-20
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-12-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-11-20
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2011-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

LX PRECISION SHANGHAI 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
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008791302. Last updated year: 2026. Please use registration number 3008791302 when referencing this establishment in official correspondence.