Orthopedic Manual Surgical Instrument
Instrument 7480117 MAS Screwdrvr T Basic
53manufacturers in China registered for this device type
2,766catalogue 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.
| 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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| 510(k) | K190840 |
| Record published | 2017-12-16 |
| Record revised | 2022-09-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Sizes | Height 5 to 8 mm; depth 12 to 18 mm; length 30 to 90 mm; outer diameter 1.5 mm |
| Distribution end date | 2026-04-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 901-526 | In distribution | ||
| 5584999 | In distribution | ||
| 8350399 | 3.2 Hex | In distribution | |
| EX1210012 | In distribution | ||
| 7480117 | In distribution | ||
| 6956011 | 2.9mm | In distribution | |
| 8350393 | 3.2mm Hex | In distribution | |
| 9359002 | In distribution | ||
| X0306446 | In distribution | ||
| X0306380 | In distribution | ||
| 9198212 | In distribution | ||
| 7967082 | In distribution | ||
| 9569312 | In distribution | ||
| 2940352 | In distribution | ||
| EX0411383 | In distribution | ||
| 7350112 | In distribution | ||
| 3606291 | In distribution | ||
| 7480396 | In distribution | ||
| 9569315 | In distribution | ||
| EX0415086 | In distribution | ||
| 5484003 | In distribution | ||
| 6642009 | In distribution | ||
| 7486217 | In distribution | ||
| 9198313 | In distribution | ||
| 4360320 | In distribution | ||
| 8114502 | 4.5mm | In distribution | |
| EX0515050 | In distribution | ||
| 5485901 | In distribution | ||
| X0497-047 | In distribution | ||
| EX1211240 | In distribution | ||
| 7480108 | In distribution | ||
| X1009556 | In distribution | ||
| 6974060 | In distribution | ||
| 6957301 | In distribution | ||
| 9490022 | In distribution | ||
| 9569631 | In distribution | ||
| 8880054 | In distribution | ||
| 7480240 | In distribution | ||
| 7485250 | In distribution | ||
| 7570946 | In distribution | ||
| 7975116 | In distribution | ||
| EX1211230 | In distribution | ||
| 7080901 | In distribution | ||
| 7480270 | In distribution | ||
| 3031070 | 7mm | In distribution | |
| 9490021 | In distribution | ||
| X3986539 | In distribution | ||
| 9296001 | In distribution | ||
| EX0115050 | In distribution | ||
| 7080919 | In distribution | ||
| X3986503 | In distribution | ||
| X7480255 | In distribution | ||
| 7484235 | In distribution | ||
| 8080533 | In distribution | ||
| EX0615014 | In distribution | ||
| 8350021 | In distribution | ||
| 9563166 | In distribution | ||
| X0807131 | In distribution | ||
| 907-510 | In distribution | ||
| 2000015 | In distribution | ||
| 9030330 | In distribution | ||
| 2900165 | In distribution | ||
| 5102916 | In distribution | ||
| 8880100 | In distribution | ||
| 8616014 | In distribution | ||
| EX0914062 | In distribution | ||
| 7756164 | In distribution | ||
| 848-930 | In distribution | ||
| 6471350 | In distribution | ||
| 9563064 | In distribution | ||
| 7350231 | In distribution | ||
| 8361954 | 3.5mm | In distribution | |
| 8350427 | 7.0mm | In distribution | |
| 8880038 | In distribution | ||
| X0711412 | In distribution | ||
| EX0911132 | In distribution | ||
| 3280009 | In distribution | ||
| EX0614106 | In distribution | ||
| 8350055 | In distribution | ||
| EX0611150 | In distribution | ||
| X0814099 | In distribution | ||
| EX0816083 | In distribution | ||
| 3280006 | In distribution | ||
| 9563165 | In distribution | ||
| 902-112 | In distribution | ||
| 5332017 | In distribution | ||
| 9569640 | In distribution | ||
| 9563082 | In distribution | ||
| 7480168 | In distribution | ||
| 902-323 | In distribution | ||
| X853-609 | In distribution | ||
| X0315077 | In distribution | ||
| 901-579 | In distribution | ||
| 9569564 | In distribution | ||
| EX0811330 | In distribution | ||
| 2940353 | In distribution | ||
| EX0414041 | In distribution | ||
| 7485248 | In distribution | ||
| EX0112084 | In distribution | ||
| 59325005 | In distribution | ||
| 5330015 | In distribution | ||
| X0202005 | In distribution | ||
| 6971547 | 7mm x 14mm | In distribution | |
| 7973121 | In distribution | ||
| 8350425 | 6.0mm | In distribution | |
| 5484211 | In distribution | ||
| 875-110 | In distribution | ||
| 7480480 | In distribution | ||
| 5484901 | In distribution | ||
| 7484175 | In distribution | ||
| 8951804 | In distribution | ||
| X0115006 | In distribution | ||
| EX0311229 | In distribution | ||
| 8361026 | 3.2mm | In distribution | |
| X1104011 | In distribution | ||
| 902-223 | In distribution | ||
| EX0816099 | In distribution | ||
| EX0715090 | In distribution | ||
| 7352034 | In distribution | ||
| 7509012 | In distribution | ||
| 890-609 | In distribution | ||
| 8110535 | In distribution | ||
| 9569560 | In distribution | ||
| 902-235 | In distribution | ||
| 7486231 | In distribution | ||
| 8880036 | In distribution | ||
| EX1114128 | In distribution | ||
| 9198310 | In distribution | ||
| 9059105 | In distribution | ||
| 8350421 | 4.0mm | In distribution | |
| EX0413049 | In distribution | ||
| 7974114 | In distribution | ||
| 7480760 | In distribution | ||
| 7484290 | In distribution | ||
| 2940051 | In distribution | ||
| 7480920 | In distribution | ||
| 9569565 | In distribution | ||
| 7576311 | In distribution | ||
| 5330000 | In distribution | ||
| EX1015008 | In distribution | ||
| 8750141 | 11mm x 14mm x 11mm | In distribution | |
| EX0615051 | In distribution | ||
| 7352030 | In distribution | ||
| 7570800 | In distribution | ||
| 6905715 | In distribution | ||
| 975-111 | 11mm x 11mm x 11mm | In distribution | |
| 902-423 | In distribution | ||
| 7480398 | In distribution | ||
| 9563181 | In distribution | ||
| EX0812953 | In distribution | ||
| 8350303 | In distribution | ||
| X0407055 | In distribution | ||
| 8295010 | In distribution | ||
| 8360203 | In distribution | ||
| 8970400 | In distribution | ||
| 1207788 | In distribution | ||
| EX0910023 | In distribution | ||
| EX0910020 | In distribution | ||
| 7480147 | In distribution | ||
| 7480126 | In distribution | ||
| X1012027 | In distribution | ||
| 7484109 | In distribution | ||
| 9115814 | In distribution | ||
| 8951811 | In distribution | ||
| 8670010 | In distribution | ||
| 7973116 | In distribution | ||
| 3280034 | In distribution | ||
| 5614560 | In distribution | ||
| 9563002 | In distribution | ||
| 7480162 | In distribution | ||
| 836-062 | 2 | In distribution | |
| 9563187 | In distribution | ||
| EX0815004 | In distribution | ||
| 6975168 | Height 8.0 mm | In distribution | |
| EX0810770 | In distribution | ||
| 5102911 | In distribution | ||
| X0809289 | In distribution | ||
| 9569621 | In distribution | ||
| 8110502 | In distribution | ||
| EX1114089 | In distribution | ||
| EX0315119 | In distribution | ||
| EX0911067 | In distribution | ||
| EX0216077 | In distribution | ||
| 6480136 | In distribution | ||
| EX0616113 | In distribution | ||
| EX0910061 | In distribution | ||
| 950-973 | (3mm x 10mm), LEFT | In distribution | |
| 7480553 | In distribution | ||
| 6956170 | In distribution | ||
| EX0215089 | In distribution | ||
| EX0812360 | In distribution | ||
| EX0806057 | In distribution | ||
| 9560631 | 1.8mm | In distribution | |
| 9198989 | In distribution | ||
| X0106150 | In distribution | ||
| 8114510 | In distribution | ||
| 8657011 | In distribution | ||
| 8530812 | In distribution | ||
| 7756171 | In distribution | ||
| 6472034 | In distribution | ||
| 6971265 | In distribution | ||
| 2941612 | In distribution | ||
| 8361025 | 3.2mm | In distribution | |
| X0109012 | In distribution | ||
| X1119042 | In distribution | ||
| 6956163 | In distribution | ||
| EX0615055 | In distribution | ||
| 9870012 | In distribution | ||
| EX0815005 | In distribution | ||
| 5598004 | In distribution | ||
| 9870008 | In distribution | ||
| X0106200 | In distribution | ||
| 900-433 | In distribution | ||
| 9339094 | In distribution | ||
| 75700350 | In distribution | ||
| EX0311223 | In distribution | ||
| 2900357 | In distribution | ||
| EX0311224 | In distribution | ||
| 9181902 | In distribution | ||
| 3280030 | In distribution | ||
| 5102021 | In distribution | ||
| 5484333 | In distribution | ||
| 6971527 | In distribution | ||
| 2000012 | In distribution | ||
| X0112002 | In distribution | ||
| 6971158 | In distribution | ||
| EX0812356 | In distribution | ||
| 875-084 | In distribution | ||
| 8350005 | In distribution | ||
| X0497-045 | In distribution | ||
| 7570945 | In distribution | ||
| 6471360 | In distribution | ||
| 609103 | 3mm x 8mm x 8mm | In distribution | |
| 2940355 | In distribution | ||
| EX0113041 | In distribution | ||
| 7974000 | In distribution | ||
| 5598043 | In distribution | ||
| 5330020 | In distribution | ||
| 975-641 | 6mm x 14mm x 11mm | In distribution | |
| 8360201 | In distribution | ||
| 8350747 | In distribution | ||
| X0805314 | In distribution | ||
| X050702916 | In distribution | ||
| X030729211 | In distribution | ||
| EX0615057 | In distribution | ||
| 9561524 | In distribution | ||
| NAV2018 | In distribution | ||
| EX0615052 | In distribution | ||
| 815-500 | In distribution | ||
| 8670004 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
| Acumed | Acumed LLC | 1,177 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | UDI-DI | 2021-11-19 | Class II | Under Investigation by firm | Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor. | 4 units |
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.