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Suzhou Elite Precision Machinery Co., Ltd.: FDA-registered device maker in Kunshan Jiangsu, China, 1 510(k) clearance

Name: Suzhou Elite Precision Machinery Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Suzhou Elite Precision Machinery Co., Ltd. is registered with the FDA (registration 3011295718) in Kunshan Jiangsu, China. It lists 35 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 27, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011295718
Address: No.498 Fengxing Rd, Huaqiao Town, Kunshan Jiangsu, China, 215332
Owner or operator: Suzhou Elite Precision Machinery Co., Ltd. (10048840)
Roles: Contract manufacturer, Manufacturer
First device listed: March 9, 2015
Registered through: 2026
Brand names listed: 14412, 14803, 3134174, 7207281, 7209214, 72201590, 72201727, 72201741 and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Contract manufacturer	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Contract manufacturer	accessdata.fda.gov
Cerclage, Fixation	JDQ	2	Contract manufacturer	accessdata.fda.gov
Component, Traction, Non-Invasive	KQZ	1	Contract manufacturer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Contract manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Contract manufacturer	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Contract manufacturer	accessdata.fda.gov
Mesh, Surgical, Acetabular, Hip, Prosthesis	JDJ	2	Contract manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer	accessdata.fda.gov
Passer	HWQ	1	Contract manufacturer	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Contract manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Femoral Component, Cemented, Metal	JDG	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal Ball	LZY	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	LWJ	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	MBL	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	NPJ	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	KRO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	HRY	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	KRR	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	KRQ	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Contract manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Contract manufacturer	accessdata.fda.gov
Software For Diagnosis/Treatment	OSN	2	Contract manufacturer	accessdata.fda.gov
Template	HWT	1	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 27, 2015	K150241	Genesis II XLPE Resurfacing Patellar Components	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 27, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.