Mondeal

MCD Screw 2.3 x 14 mm cannulated M1 partially threaded thread length 5.6 mm violet

Registry build 21.09.26
31manufacturers in China registered for this device type
525catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWC
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11

Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone

Record

Regulatory record for Mondeal
Listed by Mondeal Medical Systems GmbH, Netherlands
FDA product code HWC
Device type Screw, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3040
Record published 2017-06-26
Record revised 2024-02-19 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Distribution end date 2021-12-31
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Mondeal
Catalogue number Size Status
27-03230 Withdrawn
26-50816 Withdrawn
08-40128 Withdrawn
08-45260 Withdrawn
27-01217 Withdrawn
08-35610 Withdrawn
08-30354 Withdrawn
08-40354 Withdrawn
08-75375 Withdrawn
08-75401 Withdrawn
08-65250 Withdrawn
08-20106 Withdrawn
08-20220 Withdrawn
08-35126 Withdrawn
08-45370 Withdrawn
08-30250 Withdrawn
08-23606 Withdrawn
08-40638 Withdrawn
08-30114 Withdrawn
08-30632 Withdrawn
27-03504 Withdrawn
08-65445 Withdrawn
08-23622 Withdrawn
27-02602 Withdrawn
08-27628 Withdrawn
08-40155 Withdrawn
08-40624 Withdrawn
08-30644 Withdrawn
08-35132 Withdrawn
08-30334 Withdrawn
08-65455 Withdrawn
08-65385 Withdrawn
26-50726 Withdrawn
08-45328 Withdrawn
08-45244 Withdrawn
08-20118 Withdrawn
08-30124 Withdrawn
08-65480 Withdrawn
08-30232 Withdrawn
08-65370 Withdrawn
08-30622 Withdrawn
08-65297 Withdrawn
08-40336 Withdrawn
08-23208 Withdrawn
08-30332 Withdrawn
08-40332 Withdrawn
08-30134 Withdrawn
08-30224 Withdrawn
08-30116 Withdrawn
08-40628 Withdrawn
08-20608 Withdrawn
08-23610 Withdrawn
08-35260 Withdrawn
08-30338 Withdrawn
08-65460 Withdrawn
08-30636 Withdrawn
08-35650 Withdrawn
08-30618 Withdrawn
08-65396 Withdrawn
08-27608 Withdrawn
08-45350 Withdrawn
08-40136 Withdrawn
08-45355 Withdrawn
27-02610 Withdrawn
27-01138 Withdrawn
27-03224 Withdrawn
08-30132 Withdrawn
08-35136 Withdrawn
26-50820 Withdrawn
08-40318 Withdrawn
08-40358 Withdrawn
08-35222 Withdrawn
27-02601 Withdrawn
08-30654 Withdrawn
08-40324 Withdrawn
08-45316 Withdrawn
08-30246 Withdrawn
08-35248 Withdrawn
08-30640 Withdrawn
27-02608 Withdrawn
27-01104 Withdrawn
08-35130 Withdrawn
08-20606 Withdrawn
26-50818 Withdrawn
08-40132 Withdrawn
08-40124 Withdrawn
27-02606 Withdrawn
08-40342 Withdrawn
08-27108 Withdrawn
08-45228 Withdrawn
08-35122 Withdrawn
08-65255 Withdrawn
08-35638 Withdrawn
08-65395 Withdrawn
26-50814 Withdrawn
08-30136 Withdrawn
08-30344 Withdrawn
08-23310 Withdrawn
08-35640 Withdrawn
08-75380 Withdrawn
27-02104 Withdrawn
08-45230 Withdrawn
26-50714 Withdrawn
08-30112 Withdrawn
08-35236 Withdrawn
08-40224 Withdrawn
08-23620 Withdrawn
08-35622 Withdrawn
08-30236 Withdrawn
08-35155 Withdrawn
08-40660 Withdrawn
08-40612 Withdrawn
08-35616 Withdrawn
08-40610 Withdrawn
08-40144 Withdrawn
08-40138 Withdrawn
08-75396 Withdrawn
08-50640 Withdrawn
08-40114 Withdrawn
08-27128 Withdrawn
08-35624 Withdrawn
08-30348 Withdrawn
08-45330 Withdrawn
27-02428 Withdrawn
08-30650 Withdrawn
08-35134 Withdrawn
08-75395 Withdrawn
08-45255 Withdrawn
08-23616 Withdrawn
08-20108 Withdrawn
08-35634 Withdrawn
08-30316 Withdrawn
27-02728 Withdrawn
27-02526 Withdrawn
08-30324 Withdrawn
08-45248 Withdrawn
08-27612 Withdrawn
08-35148 Withdrawn
27-03501 Withdrawn
08-45234 Withdrawn
08-20620 Withdrawn
08-40626 Withdrawn
08-65298 Withdrawn
27-02730 Withdrawn
08-75355 Withdrawn
08-30642 Withdrawn
26-50828 Withdrawn
08-75360 Withdrawn
08-23116 Withdrawn
08-35224 Withdrawn
08-30328 Withdrawn
08-30108 Withdrawn
08-27226 Withdrawn
08-45218 Withdrawn
27-02535 Withdrawn
08-27626 Withdrawn
08-35646 Withdrawn
08-20222 Withdrawn
08-23210 Withdrawn
08-30240 Withdrawn
08-23112 Withdrawn
08-45246 Withdrawn
08-65475 Withdrawn
08-27220 Withdrawn
08-23220 Withdrawn
08-45236 Withdrawn
08-30658 Withdrawn
27-02603 Withdrawn
27-03525 Withdrawn
08-35144 Withdrawn
08-35636 Withdrawn
27-02226 Withdrawn
08-23314 Withdrawn
08-75404 Withdrawn
08-45320 Withdrawn
08-40620 Withdrawn
26-50722 Withdrawn
08-27224 Withdrawn
26-50724 Withdrawn
08-35642 Withdrawn
08-65498 Withdrawn
08-27118 Withdrawn
08-30646 Withdrawn
08-65296 Withdrawn
08-30128 Withdrawn
27-03503 Withdrawn
08-27114 Withdrawn
08-30110 Withdrawn
08-45632 Withdrawn
27-02131 Withdrawn
08-27218 Withdrawn
08-20610 Withdrawn
08-45226 Withdrawn
08-27610 Withdrawn
08-65290 Withdrawn
27-01219 Withdrawn
08-23114 Withdrawn
08-45220 Withdrawn
27-02130 Withdrawn
08-20218 Withdrawn
08-35124 Withdrawn
08-35128 Withdrawn
08-50642 Withdrawn
08-23614 Withdrawn
08-40616 Withdrawn
08-45232 Withdrawn
08-35258 Withdrawn
08-35140 Withdrawn
08-40346 Withdrawn
08-35242 Withdrawn
08-27112 Withdrawn
08-75398 Withdrawn
08-65497 Withdrawn
08-65299 Withdrawn
08-23218 Withdrawn
08-50644 Withdrawn
27-02623 Withdrawn
08-40320 Withdrawn
08-50630 Withdrawn
08-30244 Withdrawn
08-30242 Withdrawn
08-40614 Withdrawn
08-30210 Withdrawn
08-45636 Withdrawn
08-50646 Withdrawn
08-20114 Withdrawn
08-30608 Withdrawn
08-40140 Withdrawn
08-35250 Withdrawn
08-23122 Withdrawn
08-27126 Withdrawn
08-20124 Withdrawn
08-40334 Withdrawn
08-40110 Withdrawn
08-20208 Withdrawn
08-35660 Withdrawn
08-30648 Withdrawn
08-40340 Withdrawn
08-27630 Withdrawn
08-35110 Withdrawn
08-27622 Withdrawn
08-65375 Withdrawn
08-45634 Withdrawn
08-65365 Withdrawn
08-65350 Withdrawn
08-23110 Withdrawn
08-45216 Withdrawn
27-02627 Withdrawn
08-27210 Withdrawn
08-40148 Withdrawn

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Screw, Fixation, Bone Synthes Gmbh 3,975
Aptus Medartis Inc. 3,623
Acumed Acumed LLC 3,187
Arthrex® Arthrex, Inc. 2,781
OsteoMed Osteomed 2,764
Screw, Fixation, Bone AAP Implantate AG 2,176
Screw, Fixation, Bone Zimmer, Inc. 1,993
Arix System Bone Screw Jeil Medical Corporation 1,875
Cannulated Screw System + Tyber Medical 1,814
Cannulated Compression Headless Screw Tyber Medical 1,621
Microware Bone Plates and Bone Screws Microware Precision Co., Ltd. 1,601
Anthem Globus Medical, Inc. 1,538

Showing 12 of 5,775. All products under Screw, Fixation, Bone

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