Tandry CMF Plate System

1.7mm Emergency Self-tapping Screws, 12mm, Cruciform

Registry build 21.09.26
3manufacturers in China registered for this device type
140catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZL
Manufacturer City Province Registered as Device types
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Dentalmaster (Xiamen) Medical Technology Co., Ltd. Xiamen Fujian Manufacturer 1

Record

Regulatory record for Tandry CMF Plate System
Listed by Microware Precision Co., Ltd., Taiwan
FDA product code DZL
Device type Screw, Fixation, Intraosseous
Device class Class 2
Regulation 21 CFR 872.4880
Establishment Contract manufacturer, Manufacturer
510(k) K220360
Record published 2026-05-12

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Tandry CMF Plate System
Catalogue number Size Status
T50-27408 In distribution
T50-20414 In distribution
T50-20906 In distribution
T50-20504 In distribution
T50-15910 In distribution
T50-17005 In distribution
T50-20507 In distribution
T50-23416 In distribution
T50-17012 In distribution
T50-14005 In distribution
T50-12905 In distribution
T50-12005 In distribution
T50-20406 In distribution
T50-20506 In distribution
T50-15905 In distribution
T50-12912 In distribution
T50-23516 In distribution
T50-27512 In distribution
T50-27410 In distribution
T50-23520 In distribution
T50-14006 In distribution
T50-20720 In distribution
T50-14012 In distribution
T50-27508 In distribution
T50-20918 In distribution
T50-27505 In distribution
T50-23505 In distribution
T50-23406 In distribution
T50-23408 In distribution
T50-27414 In distribution
T50-20405 In distribution
T50-27520 In distribution
T50-23712 In distribution
T50-23514 In distribution
T50-12907 In distribution
T50-20706 In distribution
T50-15907 In distribution
T50-17004 In distribution
T50-14003 In distribution
T50-20412 In distribution
T50-17008 In distribution
T50-20708 In distribution
T50-23718 In distribution
T50-23504 In distribution
T50-20908 In distribution
T50-20912 In distribution
T50-20410 In distribution
T50-23716 In distribution
T50-20404 In distribution
T50-20508 In distribution
T50-20714 In distribution
T50-27418 In distribution
T50-20418 In distribution
T50-23412 In distribution
T50-17003 In distribution
T50-14010 In distribution
T50-20518 In distribution
T50-20512 In distribution
T50-12010 In distribution
T50-23410 In distribution
T50-12903 In distribution
T50-27412 In distribution
T50-15008 In distribution
T50-23720 In distribution
T50-20716 In distribution
T50-27514 In distribution
T50-12008 In distribution
T50-23420 In distribution
T50-20416 In distribution
T50-15003 In distribution
T50-23414 In distribution
T50-20712 In distribution
T50-20904 In distribution
T50-23705 In distribution
T50-27506 In distribution
T50-20407 In distribution
T50-15912 In distribution
T50-23404 In distribution
T50-20420 In distribution
T50-15903 In distribution
T50-23418 In distribution
T50-20516 In distribution
T50-14004 In distribution
T50-15904 In distribution
T50-20718 In distribution
T50-20514 In distribution
T50-15906 In distribution
T50-20704 In distribution
T50-15012 In distribution
T50-23704 In distribution
T50-12910 In distribution
T50-12012 In distribution
T50-23506 In distribution
T50-20920 In distribution
T50-14007 In distribution
T50-23710 In distribution
T50-27420 In distribution
T50-27518 In distribution
T50-12004 In distribution
T50-12904 In distribution
T50-14008 In distribution
T50-20408 In distribution
T50-27405 In distribution
T50-20710 In distribution
T50-17006 In distribution
T50-20510 In distribution
T50-20505 In distribution
T50-15005 In distribution
T50-15006 In distribution
T50-15007 In distribution
T50-15010 In distribution
T50-27406 In distribution
T50-15908 In distribution
T50-23510 In distribution
T50-23706 In distribution
T50-17007 In distribution
T50-12003 In distribution
T50-23708 In distribution
T50-27516 In distribution
T50-17010 In distribution
T50-20905 In distribution
T50-20520 In distribution
T50-12908 In distribution
T50-20910 In distribution
T50-27510 In distribution
T50-27416 In distribution
T50-23405 In distribution
T50-12906 In distribution
T50-20705 In distribution
T50-23518 In distribution
T50-15004 In distribution
T50-23407 In distribution
T50-12007 In distribution
T50-20914 In distribution
T50-23508 In distribution
T50-12006 In distribution
T50-23507 In distribution
T50-23512 In distribution
T50-20916 In distribution
T50-23714 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
OsteoMed Osteomed 1,295
Faico CMF System Faico Medical, LLC 540
Neoface Neoortho Produtos Ortopédicos S/A 181
CMF Visionare Visionare LLC 155
Universal Mandible AXS Stryker Leibinger Gmbh & Co. KG 148
Screw, Fixation, Intraosseous Synthes Gmbh 132
Level ONE CMF KLS-Martin L.P. 71
MatrixMIDFACE Synthes Gmbh 65
PlusDrive Synthes Gmbh 52
Universal 2.0 MP AXS Stryker Leibinger Gmbh & Co. KG 51
MCI – Medical Concept Innovation, Inc. MCI Medical Concept Innovation Inc. 49
CMF Southern Medical (PTY) Ltd 37

Showing 12 of 92. All products under Screw, Fixation, Intraosseous

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.

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