Plate, Bone

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shaanxi and Shanghai: 3 hold an FDA registration. 3 are contract manufacturers.

Changzhou Biomet Medical Devices Co., Ltd. Jiangsu, contract manufacturer
Kontour (Xi'an) Medical Technology Co., Ltd. Shaanxi, contract manufacturer
LX Precision Shanghai Co Ltd Shanghai, contract manufacturer

How Is JEY Classified?

Plate, Bone is FDA product code JEY, Class 2, 21 CFR 872.4760.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 111 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Process control (5), PMA (4) and Employee error (3).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Inion CPS™ Baby

1.5 x 4 mm screw (5+EMGY)

Yxoss

The FDA filing identifies Yxoss CBR as a titanium scaffold placed over bone defects to support contouring of newly formed bone. It is used in alveolar bone-defect reconstruction before…

“1MM” System Plate

2 catalogue numbers from 01-7576, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

2.0 / 1.5MM

Catalogue number SP-1769, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

Centerpiece™ Plate Fixation System

Plate 853-410 10MM Grft PLT

“1.5MM” System Bone Screw

Catalogue number 99-7285, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

Osteo-Mesh TM-300

Titanium Ridge Augmentation Mesh, 45mm x 45mm, Nonsterile, Contents: 1 Mesh

AccuStride System

3D Printed Titanium Plate

Retractor

Self Retaining, Brain, Grossman, Complete

1.0MM System

Catalogue number SP-2048, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

Leforte System Bone Screw / GBR System Bone Screw

Catalogue number 20-AT-012, listed by Jeil Medical Corporation, South Korea, under Plate, Bone. 3 manufacturers in China are registered for this product code.

1.5 System

2 catalogue numbers from 01-7186, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

2.8 Lactosorb System

2 catalogue numbers from 915-2271, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

2.0MM / 1.5MM

Catalogue number SP-1938, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

2.0MM 5×18 Hole

Catalogue number SP-1875, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

1.0MM/1.5MM System

Catalogue number 01-7465, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

1.5/2.0MM CMF System Rack

2 catalogue numbers from 15-1150, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

TraumaOne

5 catalogue numbers from SP-3448, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

Truload (TM) Screw Delivery System

3 catalogue numbers from 91-3004, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

2.0 / 1.0MM System

2 catalogue numbers from SP-1734, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

Universal Neuro 2, Quikflap

Neuro Screws,cross-Pin,self-Drilling

Thinflap System 5/PK

2 catalogue numbers from 91-6804-5PK, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

Salvin Dental Specialties

Salvin Mesh-Ti™ Titanium Mesh - 50mm x 37mm

2.8 Mm Inion CPS®

2.8 x 23 mm screw

OmniPore Surgical Implant

DUROMAX® Orbital Implant - Large - 1.5mm

2.0 MM System

Catalogue number SP-1708, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

MatrixMIDFACE

TI Matrixmidface Oblique L-PL 15MM/2X2 H/LEFT/0.7MM Thick

Midface Osteosynthesis

Osteotomy Plate, MP, BAR 8MM

Quikflap

2 Hole PLATES(3) Self Drilling SCREW(6)

1.5/2.0 CMF System

3 catalogue numbers from 15-1106, listed by Biomet Microfixation, United States, under Plate, Bone. 3 manufacturers in China are registered for this product code.

Cytoplast™ Osteo-Mesh TM-300

Titanium Ridge Augmentation Mesh, 25 mm x 34 mm, Non-sterile

Quikflap, Universal Neuro 2

LOW PROFILE BURR HOLE COVER, W/TAB, 10mm

GBR System

6 catalogue numbers from SDP-T36-022, listed by Surgident Co., Ltd., South Korea, under Plate, Bone. 3 manufacturers in China are registered for this product code.

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