Orthopedic Manual Surgical Instrument

XATP MIS Penfield Blade,140mm C-C Slot R

Registry build 21.09.26
53manufacturers in China registered for this device type
245catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LXH
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
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
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
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17

Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument

Record

Regulatory record for Orthopedic Manual Surgical Instrument
Listed by Nuvasive, Inc., United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2024-01-05
Record revised 2025-06-11 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Orthopedic Manual Surgical Instrument
Catalogue number Size Status
Z200282-81 In distribution
Z700339-02 In distribution
Z200287-141 In distribution
Z700341-309 In distribution
Z700119-01 In distribution
Z112023-7 In distribution
Z500160-26 In distribution
Z200282-80 In distribution
Z700338-45 In distribution
Z200282-220 In distribution
Z600465 In distribution
Z600089 In distribution
Z200289-180 In distribution
Z500160-526 In distribution
Z112035-520 In distribution
Z200282-161 In distribution
Z200287-60 In distribution
Z200021-14 In distribution
Z500160-32 In distribution
Z200282-100 In distribution
Z700206-502 In distribution
Z700119-02 In distribution
Z700340-02 In distribution
Z600472-10 In distribution
Z200282-141 In distribution
Z200289-60 In distribution
Z700336-105 In distribution
Z200287-121 In distribution
Z700336-104 In distribution
Z112035-20 In distribution
Z121060-501 In distribution
Z200290-180 In distribution
Z112023-607 In distribution
Z200282-160 In distribution
Z112023-2 In distribution
Z700336-106 In distribution
Z700336-306 In distribution
Z200282-201 In distribution
Z700336-111 In distribution
Z500160-520 In distribution
Z700104 In distribution
Z200290-160 In distribution
Z700336-108 In distribution
Z112023-601 In distribution
Z118084-320 In distribution
Z700341-109 In distribution
Z700006-40 In distribution
Z700336-310 In distribution
Z200288 In distribution
Z700341-103 In distribution
Z700336-501 In distribution
Z200292-090 In distribution
Z200290-200 In distribution
Z700006-30 In distribution
Z700336-305 In distribution
Z700336-101 In distribution
Z600472-300 In distribution
Z700341-310 In distribution
Z700336-311 In distribution
Z700206-2 In distribution
Z121060-02 In distribution
Z700336-304 In distribution
Z700336-507 In distribution
Z700337-85 In distribution
Z121060-01 In distribution
Z700341-102 In distribution
Z700315-208 In distribution
Z200287-160 In distribution
Z112023-605 In distribution
Z600472-21 In distribution
Z700336-102 In distribution
Z200290-80 In distribution
Z700337-55 In distribution
Z500165-49 In distribution
Z200287-80 In distribution
Z700341-308 In distribution
Z700336-309 In distribution
Z700315-306 In distribution
Z700315-305 In distribution
Z112103-01 In distribution
Z700315-308 In distribution
Z200290-140 In distribution
Z200282-081 In distribution
Z700341-107 In distribution
Z700336-502 In distribution
Z400099-01 In distribution
Z700341-110 In distribution
Z114043-02 In distribution
Z700341-101 In distribution
Z700139 In distribution
Z112023-3 In distribution
Z200287-101 In distribution
Z112023-604 In distribution
Z200123-04 In distribution
Z112023-6 In distribution
Z200287-61 In distribution
Z200291-002 In distribution
Z700006-60 In distribution
Z700336-308 In distribution
Z112023-4 In distribution
Z200291-502 In distribution
Z700336-503 In distribution
Z112035-40 In distribution
Z700338-35 In distribution
Z200292-130 In distribution
Z700336-301 In distribution
Z200287-81 In distribution
Z600027-500 In distribution
Z118084-322 In distribution
Z700341-106 In distribution
Z200287-201 In distribution
Z200289-160 In distribution
Z500164 In distribution
Z700338-65 In distribution
Z200289-120 In distribution
Z500160-532 In distribution
Z700336-509 In distribution
Z700336-510 In distribution
Z118084-318 In distribution
Z116019-2 In distribution
Z200123-08 In distribution
Z900034-45 In distribution
Z200290-100 In distribution
Z600472-1 In distribution
Z500161-02 In distribution
Z700315-310 In distribution
Z700336-303 In distribution
Z700315-309 In distribution
Z700315-307 In distribution
Z700337-35 In distribution
Z700341-311 In distribution
Z200292-140 In distribution
Z700006-70 In distribution
Z200290-220 In distribution
Z200287-120 In distribution
Z112035-540 In distribution
Z700341-305 In distribution
Z116019-1 In distribution
Z200282-200 In distribution
Z700336-508 In distribution
Z700333-01 In distribution
Z700341-111 In distribution
Z700338-85 In distribution
Z500165-48 In distribution
Z600464 In distribution
Z700315-206 In distribution
Z400100-02 In distribution
Z700315-210 In distribution
Z600468 In distribution
Z112023-606 In distribution
Z200282-221 In distribution
Z700336-109 In distribution
Z200289-220 In distribution
Z200287-140 In distribution
Z700206-501 In distribution
Z700341-108 In distribution
Z200287-220 In distribution
Z700337-65 In distribution
Z200282-101 In distribution
Z700336-110 In distribution
Z700336-506 In distribution
Z700338-55 In distribution
Z900034-450 In distribution
Z700336-300 In distribution
Z200287-181 In distribution
Z113037-022 In distribution
Z600472-11 In distribution
Z200282-080 In distribution
Z700336-100 In distribution
Z700335 In distribution
Z900035 In distribution
Z200123-12 In distribution
Z112023-602 In distribution
Z500163 In distribution
Z120001 In distribution
Z700337-75 In distribution
Z700339-01 In distribution
Z200123-10 In distribution
Z600469 In distribution
Z700341-304 In distribution
Z700341-300 In distribution
Z200282-061 In distribution
Z700222-14 In distribution
Z400100-01 In distribution
Z700341-100 In distribution
Z112023-1 In distribution
Z700341-301 In distribution
Z700338-75 In distribution
Z200292-110 In distribution
Z700336-302 In distribution
Z700341-303 In distribution
Z400100 In distribution
Z700337-45 In distribution
Z700340-01 In distribution
Z200289-80 In distribution
Z700340 In distribution
Z700341-104 In distribution
Z700336-500 In distribution
Z200290-120 In distribution
Z200287-100 In distribution
Z700341-306 In distribution
Z200282-60 In distribution
Z200287-200 In distribution
Z200292-100 In distribution
Z114043-01 In distribution
Z200289-200 In distribution
Z700315-207 In distribution
Z700341-105 In distribution
Z200282-140 In distribution
Z112023-5 In distribution
Z700341-302 In distribution
Z200021-16 In distribution
Z200287-221 In distribution
Z200287-161 In distribution
Z700336-103 In distribution
Z700336-107 In distribution
Z600466 In distribution
Z200282-61 In distribution
Z400099-02 In distribution
Z200282-060 In distribution
Z700222-12 In distribution
Z700206-1 In distribution
Z121060-500 In distribution
Z700339 In distribution
Z112023-603 In distribution
Z500160-20 In distribution
Z200292-120 In distribution
Z300157 In distribution
Z700341-307 In distribution
Z700332-03 In distribution
Z700315-205 In distribution
Z700336-505 In distribution
Z200292-150 In distribution
Z700336-504 In distribution
Z700336-511 In distribution
Z200289-140 In distribution
Z600472-20 In distribution
Z700315-209 In distribution
Z200287-180 In distribution
Z500161-01 In distribution
Z200289-100 In distribution
Z200286 In distribution
Z700336-307 In distribution
Z700006-50 In distribution
Z200290-60 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Razek Equipamentos Razek Equipamentos Ltda 11,578
Orthopedic Manual Surgical Instrument Globus Medical, Inc. 4,784
Instrument Howmedica Osteonics Corp 4,539
Orthopedic Manual Surgical Instrument Ortho Development Corp. 4,076
Knee Instruments Medacta International SA 3,944
Kyocera Medical Technologies, Inc. Kyocera Medical Technologies, Inc. 3,420
Arthrex® Arthrex, Inc. 3,106
Spine Instruments Medacta International SA 2,892
Orthopedic Manual Surgical Instrument Medtronic Sofamor Danek, Inc. 2,766
Hip Instruments Medacta International SA 1,904
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 1,756
ReLine Nuvasive, Inc. 1,208

Showing 12 of 9,501. All products under Orthopedic Manual 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