Acumed
0.062 x 9.25 ST Wire,10 Pack - 80-0950-S
53manufacturers in China registered for this device type
1,177catalogue numbers in this listing
2recalls on this code
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 | Acumed LLC, 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, Manufacturer |
| 510(k) | K251132 |
| Record published | 2015-10-24 |
| Record revised | 2025-11-20 (version 8) |
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 |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature up to 120 °F |
| Distribution end date | 2023-06-23 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 80-0175 | In distribution | ||
| 80-0323 | In distribution | ||
| 80-4292 | In distribution | ||
| TR-TS70 | In distribution | ||
| 80-2535 | In distribution | ||
| MS-SS23 | In distribution | ||
| 80-2011 | In distribution | ||
| MS-TAG20 | In distribution | ||
| 80-2233 | In distribution | ||
| HR-WA50 | In distribution | ||
| WS-2009ST | In distribution | ||
| AT-7079 | In distribution | ||
| 80-1635 | In distribution | ||
| TR-TS96 | In distribution | ||
| 80-0570 | In distribution | ||
| 80-1706 | In distribution | ||
| 80-2505 | In distribution | ||
| 80-1621 | In distribution | ||
| 45-0077 | 10 | In distribution | |
| MS-T1212 | In distribution | ||
| 80-0636 | In distribution | ||
| HPC-0025 | In distribution | ||
| 80-1144 | In distribution | ||
| 80-1585 | In distribution | ||
| 80-0600-S | In distribution | ||
| MS-9020 | In distribution | ||
| 45-0044-S | 10 | In distribution | |
| 80-0664 | In distribution | ||
| 80-0980 | In distribution | ||
| 45-0086-S | 10 | In distribution | |
| HR-3104 | In distribution | ||
| HD-3016 | In distribution | ||
| 45-0061 | 10 | In distribution | |
| TR-TSL06L | In distribution | ||
| DRB1115 | In distribution | ||
| 80-2370 | In distribution | ||
| TR-TS72 | In distribution | ||
| CO-S2320-S | In distribution | ||
| 80-0494 | In distribution | ||
| MS-8043 | In distribution | ||
| 80-1710 | In distribution | ||
| WS-1609ST-S | In distribution | ||
| TR-TS84 | In distribution | ||
| 80-1140 | In distribution | ||
| 80-0174 | In distribution | ||
| 80-1591 | In distribution | ||
| 80-0368 | In distribution | ||
| 80-1568 | In distribution | ||
| 45-0029-S | In distribution | ||
| 80-2317 | In distribution | ||
| 35-0011 | In distribution | ||
| AM-TA30 | In distribution | ||
| 80-1008 | In distribution | ||
| E-40-0016 | In distribution | ||
| SH-B1540R | In distribution | ||
| RA-0622 | In distribution | ||
| 45-0031-S | In distribution | ||
| AP-4516 | In distribution | ||
| MS-48245 | In distribution | ||
| PL-20CLAMP | In distribution | ||
| 80-2164 | In distribution | ||
| 80-1675 | In distribution | ||
| 80-4350 | In distribution | ||
| 80-1134 | In distribution | ||
| 80-0260 | In distribution | ||
| MS-TGLS | In distribution | ||
| 80-0362 | In distribution | ||
| HDF-1500 | In distribution | ||
| 45-0069 | 10 | In distribution | |
| 35-0026 | In distribution | ||
| MS-PHGL | In distribution | ||
| 80-1882 | In distribution | ||
| TR-TSL07L | In distribution | ||
| 80-0971 | In distribution | ||
| 80-0574 | In distribution | ||
| TR-TSL10 | In distribution | ||
| 80-0815 | In distribution | ||
| CO-S2316-S | In distribution | ||
| CO-S2316 | In distribution | ||
| MS-CT21 | In distribution | ||
| MS-DC5020 | In distribution | ||
| TR-TSL06 | In distribution | ||
| 80-2365 | In distribution | ||
| 80-0718 | In distribution | ||
| LAG-1000 | In distribution | ||
| WS-0704ST-S | In distribution | ||
| AI-NG16-S | In distribution | ||
| CO-S2310 | In distribution | ||
| MTP-F014 | In distribution | ||
| AI-NG24 | In distribution | ||
| 01-0013-S | In distribution | ||
| WS-1407ST | In distribution | ||
| 01-0001-S | In distribution | ||
| E-30-0033 | In distribution | ||
| 80-1128 | In distribution | ||
| 80-1525 | In distribution | ||
| WS-1609STT | In distribution | ||
| SH-5123-S | In distribution | ||
| TR-BRA08 | In distribution | ||
| 45-0030-S | In distribution | ||
| 80-0238 | In distribution | ||
| 80-0302 | In distribution | ||
| 80-2315 | In distribution | ||
| PL-BG07 | In distribution | ||
| PL-CLVB | In distribution | ||
| 80-2244 | In distribution | ||
| 80-2027 | In distribution | ||
| 80-2193 | In distribution | ||
| 80-0632 | In distribution | ||
| 30-0033-S | In distribution | ||
| 80-1657 | In distribution | ||
| 80-4322 | In distribution | ||
| WS-0706ST-S | In distribution | ||
| MTP-M014 | In distribution | ||
| 80-0862 | In distribution | ||
| 45-0034-S | 10 | In distribution | |
| AM-5020 | In distribution | ||
| 80-1884 | In distribution | ||
| 80-2240 | In distribution | ||
| 80-0495 | In distribution | ||
| 80-1145 | In distribution | ||
| 80-1551 | In distribution | ||
| HR-5101 | In distribution | ||
| BG-8044 | In distribution | ||
| HT-2502 | In distribution | ||
| PL-ELT1035 | In distribution | ||
| 80-2224 | In distribution | ||
| 80-4295 | In distribution | ||
| 80-2221 | In distribution | ||
| 80-0950 | In distribution | ||
| 80-1775 | In distribution | ||
| 80-2018 | In distribution | ||
| 80-0150 | In distribution | ||
| HT-4000 | In distribution | ||
| SH-4321-S | In distribution | ||
| TR-TS114 | In distribution | ||
| SH-4718-S | In distribution | ||
| 80-0598 | In distribution | ||
| 80-2006 | In distribution | ||
| WS-2408ST | In distribution | ||
| 80-1089-S | In distribution | ||
| 80-1277 | In distribution | ||
| 40-0032 | In distribution | ||
| 80-1564 | In distribution | ||
| 80-1840 | In distribution | ||
| 80-2373 | In distribution | ||
| PL-2320 | In distribution | ||
| HK-0024 | In distribution | ||
| MS-LTT27 | In distribution | ||
| 80-1769 | In distribution | ||
| 80-2376 | In distribution | ||
| HR-WC50-S | In distribution | ||
| 45-0040-S | 10 | In distribution | |
| 80-1597 | In distribution | ||
| 80-3885 | In distribution | ||
| 80100102 | In distribution | ||
| 80-1012 | In distribution | ||
| TR-TSL09L | In distribution | ||
| 80-1592 | In distribution | ||
| 80-1590 | In distribution | ||
| HDL-2000 | In distribution | ||
| 80-4310 | In distribution | ||
| 80-0423 | In distribution | ||
| 80-2496 | In distribution | ||
| 55-0003-S | In distribution | ||
| 80-4169 | In distribution | ||
| CO-S2324-S | In distribution | ||
| 35-0032 | In distribution | ||
| 80-1991 | In distribution | ||
| 80-2074 | In distribution | ||
| 80-0094 | In distribution | ||
| 80-0555 | In distribution | ||
| 7003-10046 | In distribution | ||
| CO-S2330 | In distribution | ||
| WS-2009ST-S | In distribution | ||
| 45-0035-S | 10 | In distribution | |
| 7003-13067-S | In distribution | ||
| MS-45300 | In distribution | ||
| HT-0915 | In distribution | ||
| 80-1617 | In distribution | ||
| 80-1545 | In distribution | ||
| SH-0103 | In distribution | ||
| MS-DC15 | In distribution | ||
| MS-TT21 | In distribution | ||
| 80-0635 | In distribution | ||
| MS-47959 | In distribution | ||
| SMC-5090 | In distribution | ||
| 80-4307 | In distribution | ||
| PL-CL03 | In distribution | ||
| 80-2236 | In distribution | ||
| 45-0028-S | 10 | In distribution | |
| 80-1538 | In distribution | ||
| AI-NG14 | In distribution | ||
| WS-1406ST-S | In distribution | ||
| MTP-M024 | In distribution | ||
| 80-0768 | In distribution | ||
| 80-1625 | In distribution | ||
| CO-S2312-S | In distribution | ||
| MTP-F024 | In distribution | ||
| 80-4319 | In distribution | ||
| SH-B1340L | In distribution | ||
| 80-1618 | In distribution | ||
| 80-0477 | In distribution | ||
| CO-S2318 | In distribution | ||
| HRDR001 | In distribution | ||
| AI-NG22-S | In distribution | ||
| 4002-10240-S | In distribution | ||
| CO-S2344 | In distribution | ||
| 35-0008 | In distribution | ||
| 80-0146 | In distribution | ||
| 80-0418 | In distribution | ||
| 45-0076 | 10 | In distribution | |
| 35-0025 | In distribution | ||
| 80-1524-S | In distribution | ||
| 80-2195 | In distribution | ||
| 80-0482 | In distribution | ||
| CO-S2322-S | In distribution | ||
| TR-TS112 | In distribution | ||
| 80-4298 | In distribution | ||
| 55-0001-S | In distribution | ||
| 35-0027 | In distribution | ||
| 80-0483 | In distribution | ||
| TR-TH26R | In distribution | ||
| 80-0659 | In distribution | ||
| MS-0200 | In distribution | ||
| SH-B1340R | In distribution | ||
| AT-7020 | In distribution | ||
| 01-0011-S | In distribution | ||
| 80-0775 | In distribution | ||
| 80-1577 | In distribution | ||
| HR-SG50 | In distribution | ||
| 80-2473 | In distribution | ||
| PL-SR38 | In distribution | ||
| PL-SR30 | In distribution | ||
| 80-1506 | In distribution | ||
| 80-0634 | In distribution | ||
| SM-5015 | In distribution | ||
| 80-0729 | In distribution | ||
| 80-0844 | In distribution | ||
| 80-0619 | In distribution | ||
| BG-8043 | In distribution | ||
| 80-2038 | In distribution | ||
| 80-0720 | In distribution | ||
| CO-S2320 | In distribution | ||
| 80-2242 | In distribution | ||
| 15500105 | In distribution | ||
| MS-2800 | In distribution | ||
| 45-0087-S | 10 | In distribution | |
| 80-2237 | In distribution | ||
| TR-TS102 | 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 |
| 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
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-11-27 | Class II | Unknown/Undetermined by firm | Due to potential breakage during use. | 513 units | |
| 2017-02-17 | Class II | Process control | Guide wires sized as.045 X 6 were mis-packaged as.054 X 7 guide wires and those sized as.054 X 7 were mis- packaged as.045 X 6 guide wires. There is a possibility that using the incorrect guide wire size can cause health hazards, such | 24 units of.045 X 6 ST Guide Wire and 25 units of.054 X 7 | 2017-05-19 |
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.