Suzhou Elite Precision Machinery Co., Ltd.

Registered establishment in Kunshan, Jiangsu, China. 35 device types.

Registry build 21.09.26

Suzhou Elite Precision Machinery Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Passer, Template and 33 other device types. Its earliest product listing with the FDA dates from 2015.

Registration

FDA registration record for Suzhou Elite Precision Machinery Co., Ltd.
Status Registered
Registration expires 2026
Registration number 3011295718
FEI number 3011295718
Establishment type Contract manufacturer, Manufacturer

Location

Address of Suzhou Elite Precision Machinery Co., Ltd.
City Kunshan
Province Jiangsu
Address No.498 Fengxing Rd, Huaqiao Town
Postal code 215332
Country China

What It Makes

Device types Suzhou Elite Precision Machinery Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessories, Arthroscopic Class 1 810599701, 72201727, 72201742, 72201590, 72201743, 14803 and 3 more 2017 14
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class 2 Ilizarov, TSF 2015 17
Cerclage, Fixation Class 2 Reflection 2015 5
Component, Traction, Non-Invasive Class 1 3134174 2017 18
Fastener, Fixation, Nondegradable, Soft Tissue Class 2 72202755, 72202757, 72202758, 72202756, 72201882, 72201881 2017 7
Guide, Surgical, Instrument Class 1 Peri-LOC 2016 26
Instrument, Bending Or Contouring Class 1 Peril-LOC 2016 5
Mesh, Surgical, Acetabular, Hip, Prosthesis Class 2 Reflection 2015 2
Orthopedic Manual Surgical Instrument Class 1 Extender, Set Screw Driver, Journey TKA AP FEM CUT BLK Knob, O/MFG Patella Housing, O/MFG Trial Shell Handle, Weld TIB ART Isrt IMP/EXT S/A 2015 53
Passer Class 1 72202193, 72202191, 72202192 2017 6
Pin, Fixation, Threaded Class 2 Ilizarov Systems, Other External Fixation 2019 9
Plate, Fixation, Bone Class 2 Peri-LOC 2016 22
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Class 2 Reflection 2015 10
Prosthesis, Hip, Femoral Component, Cemented, Metal Class 2 Reflection 2015 5
Prosthesis, Hip, Hemi-, Femoral, Metal Class 2 Reflection 2015 10
Prosthesis, Hip, Hemi-, Femoral, Metal Ball Class 2 Reflection 2015 5
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class 2 Reflection 2015 14
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 Reflection 2015 15
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class 2 Reflection 2015 13
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class 2 OR30 Dual mobility trial insert locking ring 22 ID, OR30 Dual Mobility System, Reflection 2015 14
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Class 2 Reflection 2015 9
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 Reflection 2015 14
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class 2 Reflection 2015 5
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class 2 Gll DCF VRBL SZ GUIDE LT, Gll DCF VRBL SZ GUIDE RT, Genesis, Journey, Journey II UNI 2015 3
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Class 2 Gll DCF VRBL SZ GUIDE LT, Gll DCF VRBL SZ GUIDE RT, Genesis, Journey, Genesis II oval resurfacing patellar trial 2015 7
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Class 2 Journey, Gll DCF VRBL SZ GUIDE LT, Gll DCF VRBL SZ GUIDE RT, Genesis, Journey II UNI 2015 6
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Class 2 Gll DCF VRBL SZ GUIDE LT, Gll DCF VRBL SZ GUIDE RT, Genesis, Journey 2015 10
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Class 2 Gll DCF VRBL SZ GUIDE LT, Gll DCF VRBL SZ GUIDE RT, Genesis, Journey, Genesis II oval resurfacing patellar trial, Journey II UNI 2015 7
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer Class 2 Gll DCF VRBL SZ GUIDE LT, Gll DCF VRBL SZ GUIDE RT, Genesis, Journey 2015 3
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 Gll DCF VRBL SZ GUIDE LT, Gll DCF VRBL SZ GUIDE RT, Genesis, Journey, Genesis II oval resurfacing patellar trial 2015 12
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class 2 Gll DCF VRBL SZ GUIDE LT, Gll DCF VRBL SZ GUIDE RT, Genesis, Journey, Genesis II oval resurfacing patellar trial, Anthem 2015 21
Screw, Fixation, Bone Class 2 72201805 2017 31
Screwdriver Class 1 Imhs 2015 18
Software For Diagnosis/Treatment Class 2 Ilizarov, TSF 2015 3
Template Class 1 14412, 7209214 2017 21

Clearances

No clearance names Suzhou Elite Precision Machinery Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Suzhou Elite Precision Machinery Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K150241 2015-10-27 JWH Traditional Smith & Nephew, Inc.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Suzhou Elite Precision Machinery Co., Ltd.
Founded 2004
Factory area 11,600 sq m
Main products Precision machining parts, Equipment assemblies, Weldments
Certifications ISO 9001

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer