DJO Surgical

HXL/FMP Acetabular Trial Liner, NON-Hooded 44MM/76MM Multi Hole

Registry build 21.09.26
26manufacturers in China registered for this device type
284catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Zhejiang (5), Guangdong (4). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FZX
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13

Showing 12 of 26. All 26 manufacturers in China registered for Guide, Surgical, Instrument

Record

Regulatory record for DJO Surgical
Listed by DJO, LLC, United States
FDA product code FZX
Device type Guide, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-06-29
Record revised 2024-06-13 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for DJO Surgical
Catalogue number Size Status
801-01-657 In distribution
800-01-295 In distribution
802-01-070 In distribution
801-01-527 In distribution
803-05-007 In distribution
803-20-040 In distribution
801-04-083 In distribution
802-01-091 In distribution
801-01-502 In distribution
803-05-050 In distribution
803-05-068 In distribution
801-01-540 In distribution
801-01-307 In distribution
801-01-546 In distribution
801-04-107 In distribution
803-05-081 In distribution
80101155 In distribution
801-01-503 In distribution
80101733 In distribution
801-01-507 In distribution
803-05-086 In distribution
801-01-240 In distribution
801-01-543 In distribution
804-02-089 In distribution
804-25-132 In distribution
80101143 In distribution
803-51-381 In distribution
803-05-063 In distribution
801-01-572 In distribution
801-01-498 In distribution
800-01-181 In distribution
801-01-552 In distribution
801-01-517 In distribution
80101144 In distribution
803-05-076 In distribution
S-200860 In distribution
803-05-041 In distribution
801-01-506 In distribution
803-03-042 In distribution
803-55-445 In distribution
803-05-087 In distribution
801-01-512 In distribution
803-00-028 In distribution
801-04-058 In distribution
803-05-078 In distribution
802-01-086 In distribution
801-04-084 In distribution
803-53-444 In distribution
804-25-102 In distribution
801-01-265 In distribution
803-05-083 In distribution
80101423 In distribution
801-01-495 In distribution
80101151 In distribution
801-01-121 In distribution
803-21-027 In distribution
801-01-122 In distribution
801-01-371 In distribution
803-53-381 In distribution
800-01-182 In distribution
801-04-060 In distribution
80101169 In distribution
800-03-036 In distribution
80101162 In distribution
801-01-508 In distribution
803-21-026 In distribution
803-03-041 In distribution
803-55-446 In distribution
S-200698 In distribution
80101163 In distribution
801-01-510 In distribution
803-51-445 In distribution
802-01-076 In distribution
803-05-051 In distribution
80101153 In distribution
80101168 In distribution
803-84-438 In distribution
800-01-378 In distribution
80101141 In distribution
803-05-085 In distribution
801-01-523 In distribution
803-05-101 In distribution
801-01-126 In distribution
803-05-150 In distribution
80101154 In distribution
801-01-538 In distribution
801-01-521 In distribution
801-01-050 In distribution
801-01-416 In distribution
801-01-545 In distribution
803-05-006 In distribution
803-05-079 In distribution
80101164 In distribution
80101150 In distribution
803-20-062 In distribution
801-01-520 In distribution
804-25-129 In distribution
801-01-224 In distribution
801-01-660 In distribution
803-53-446 In distribution
801-04-106 In distribution
803-52-445 In distribution
803-05-012 In distribution
80101166 In distribution
803-05-067 In distribution
801-01-534 In distribution
803-05-062 In distribution
802-05-004 In distribution
803-00-030 In distribution
801-01-541 In distribution
800-01-297 In distribution
801-04-082 In distribution
801-01-175 In distribution
803-05-009 In distribution
803-05-016 In distribution
801-01-525 In distribution
803-05-045 In distribution
803-05-084 In distribution
803-05-010 In distribution
801-01-516 In distribution
801-04-080 In distribution
801-01-417 In distribution
801-01-519 In distribution
801-01-536 In distribution
804-25-124 In distribution
80101152 In distribution
801-04-056 In distribution
804-25-127 In distribution
804-00-146 In distribution
803-05-138 In distribution
801-04-105 In distribution
80101140 In distribution
80101421 In distribution
803-05-082 In distribution
802-01-085 In distribution
801-01-547 In distribution
804-25-105 In distribution
803-84-338 In distribution
803-52-381 In distribution
801-01-501 In distribution
801-01-415 In distribution
801-01-549 In distribution
801-01-528 In distribution
804-25-040 In distribution
803-00-114 In distribution
802-01-089 In distribution
801-01-310 In distribution
801-04-081 In distribution
803-05-014 In distribution
803-52-444 In distribution
803-20-064 In distribution
802-01-075 In distribution
801-01-530 In distribution
801-01-418 In distribution
801-01-509 In distribution
803-05-099 In distribution
801-01-308 In distribution
801-01-551 In distribution
801-01-496 In distribution
80101731 In distribution
803-05-052 In distribution
801-01-497 In distribution
803-03-043 In distribution
800-01-033 In distribution
80101165 In distribution
80101157 In distribution
803-05-064 In distribution
803-20-039 In distribution
801-01-526 In distribution
801-01-524 In distribution
803-00-101 In distribution
801-01-539 In distribution
803-05-049 In distribution
801-01-544 In distribution
804-00-046 In distribution
800-01-177 In distribution
803-05-048 In distribution
80101159 In distribution
803-05-065 In distribution
801-01-548 In distribution
804-25-101 In distribution
803-05-165 In distribution
802-05-003 In distribution
803-54-446 In distribution
803-05-017 In distribution
804-25-103 In distribution
801-01-400 In distribution
80101161 In distribution
803-51-444 In distribution
801-01-522 In distribution
801-04-104 In distribution
801-01-500 In distribution
801-01-264 In distribution
801-01-271 In distribution
801-01-533 In distribution
803-01-100 In distribution
801-01-656 In distribution
800-01-178 In distribution
803-05-066 In distribution
803-84-538 In distribution
803-55-444 In distribution
800-03-035 In distribution
801-01-518 In distribution
80101167 In distribution
803-05-047 In distribution
801-01-553 In distribution
804-00-047 In distribution
801-04-059 In distribution
804-25-125 In distribution
801-01-139 In distribution
803-05-098 In distribution
803-05-097 In distribution
80101730 In distribution
801-01-413 In distribution
801-01-535 In distribution
801-01-273 In distribution
804-25-148 In distribution
801-01-531 In distribution
801-01-450 In distribution
803-20-038 In distribution
803-03-012 In distribution
801-01-515 In distribution
803-05-069 In distribution
80101419 In distribution
801-01-650 In distribution
800-01-179 In distribution
801-01-537 In distribution
803-05-015 In distribution
801-01-505 In distribution
803-00-029 In distribution
80101156 In distribution
801-01-306 In distribution
801-01-513 In distribution
80101160 In distribution
803-05-166 In distribution
803-05-301 In distribution
801-01-542 In distribution
803-84-238 In distribution
801-04-108 In distribution
803-51-446 In distribution
800-01-296 In distribution
801-04-057 In distribution
803-05-011 In distribution
804-25-126 In distribution
801-01-241 In distribution
803-05-005 In distribution
801-01-499 In distribution
803-52-446 In distribution
804-25-104 In distribution
801-01-514 In distribution

Showing 250 of 284 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DJO Surgical Encore Medical, L.P. 2,141
Guide, Surgical, Instrument Synthes Gmbh 727
Apex Knee System Omni Life Science, Inc. 272
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 223
Motoband CP Crossroads Extremity Systems LLC 221
Advance® Microport Orthopedics Inc. 199
NexGen® Zimmer, Inc. 194
Evolution® Microport Orthopedics Inc. 173
Innomed, Inc. Innomed, Inc. 172
Newclip Instruments Newclip Technics SAS 144
Guide, Surgical, Instrument Zimmer, Inc. 135
Natural Knee® Zimmer, Inc. 134

Showing 12 of 1,788. All products under Guide, Surgical, Instrument

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