Orthopedic Manual Surgical Instrument
XATP MIS Penfield Blade,140mm C-C Slot R
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.
| 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
| 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
| 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 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 | |
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| Z700336-104 | In distribution | |
| Z112035-20 | In distribution | |
| Z121060-501 | In distribution | |
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| Z500160-520 | In distribution | |
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| Z200290-160 | In distribution | |
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| Z200287-81 | In distribution | |
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| Z700341-106 | In distribution | |
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| Z200289-160 | In distribution | |
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| Z700341-311 | In distribution | |
| Z200292-140 | In distribution | |
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| Z200290-220 | In distribution | |
| Z200287-120 | In distribution | |
| Z112035-540 | In distribution | |
| Z700341-305 | In distribution | |
| Z116019-1 | In distribution | |
| Z200282-200 | In distribution | |
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| Z700341-111 | In distribution | |
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| Z600468 | In distribution | |
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| 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 | |
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| Z900034-450 | In distribution | |
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| Z700339-01 | In distribution | |
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| 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 | |
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| 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 | |
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| Z700006-50 | In distribution | |
| Z200290-60 | In distribution |
Same 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.