Orthopedic Manual Surgical Instrument
ACL Disposables Kit 18 Inches Bayonet Point Passing Pin (2.4 x 45 cm), 14 Inches Drill Tip Passing Pin (2.4 x 35 cm), 1.1 mm x 15 Inches (38 cm) Nitinol Guidewire, Threaded Tibial Cannula,…
ACL Disposables Kit 18 Inches Bayonet Point Passing Pin (2.4 x 45 cm), 14 Inches Drill Tip Passing Pin (2.4 x 35 cm), 1.1 mm x 15 Inches (38 cm) Nitinol Guidewire, Threaded Tibial Cannula, Malleable Graft Retractor, Marking Pen, Ruler (Percent accuracy = Plus or Minus 1 Percent)
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 | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2016-07-15 |
| Record revised | 2025-03-18 (version 7) |
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 |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 26 °C; Handling environment temperature up to 80 °F; Storage environment temperature up to 80 °F; Handling environment temperature up to 26 °C |
| Packaging | Package of 6 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 288209 | In distribution | ||
| 270127 | In distribution | ||
| 219971 | In distribution | ||
| 214639 | In distribution | ||
| 288238 | In distribution | ||
| 260009 | In distribution | ||
| 288211 | In distribution | ||
| 219959 | In distribution | ||
| 288212 | In distribution | ||
| 214629 | In distribution | ||
| 254686 | In distribution | ||
| 260011 | In distribution | ||
| 219992 | In distribution | ||
| 219974 | In distribution | ||
| 219621 | In distribution | ||
| 254847 | In distribution | ||
| 254715 | In distribution | ||
| 232300 | In distribution | ||
| 211313 | In distribution | ||
| 219968 | In distribution | ||
| 254730 | In distribution | ||
| 698345126 | In distribution | ||
| 219958 | In distribution | ||
| 214152 | In distribution | ||
| 697100067 | In distribution | ||
| 698345166 | In distribution | ||
| 2860-05-001 | In distribution | ||
| 698345152 | In distribution | ||
| 219203 | In distribution | ||
| 698345131 | In distribution | ||
| 270105 | In distribution | ||
| 219441 | In distribution | ||
| 698345125 | In distribution | ||
| 214614 | In distribution | ||
| 288215 | In distribution | ||
| 214608 | In distribution | ||
| 219440 | In distribution | ||
| 214111 | In distribution | ||
| 219204 | In distribution | ||
| 219653 | In distribution | ||
| 288204 | In distribution | ||
| 219963 | In distribution | ||
| 254605 | In distribution | ||
| 254844 | In distribution | ||
| 214103 | In distribution | ||
| 232002 | In distribution | ||
| 219965 | In distribution | ||
| 288214 | In distribution | ||
| 214117 | In distribution | ||
| 214628 | In distribution | ||
| 219652 | In distribution | ||
| 219966 | In distribution | ||
| 698345092 | In distribution | ||
| 698345122 | In distribution | ||
| 219962 | In distribution | ||
| 219960 | In distribution | ||
| 254672 | In distribution | ||
| 219964 | In distribution | ||
| 219993 | In distribution | ||
| 214610 | In distribution | ||
| 288210 | In distribution | ||
| 288213 | In distribution | ||
| 219445 | In distribution | ||
| 254843 | In distribution | ||
| 3010-21-340 | In distribution | ||
| 211315 | In distribution | ||
| 219447 | In distribution | ||
| 219961 | In distribution | ||
| 219994 | In distribution | ||
| 219443 | In distribution | ||
| 214613 | In distribution | ||
| 219448 | In distribution | ||
| 219957 | In distribution | ||
| 219991 | In distribution | ||
| 288206 | In distribution | ||
| 214609 | In distribution | ||
| 288205 | In distribution | ||
| 214611 | In distribution | ||
| 260012 | In distribution | ||
| 288240 | In distribution | ||
| 698345036 | In distribution | ||
| 288200 | In distribution | ||
| 232024 | 5 | In distribution | |
| 288203 | In distribution | ||
| 288101 | In distribution | ||
| 214711 | In distribution | ||
| 214710 | In distribution | ||
| 698345096 | In distribution | ||
| 214119 | In distribution | ||
| 260003 | In distribution | ||
| 219444 | In distribution | ||
| 214612 | In distribution | ||
| 260010 | In distribution | ||
| 254687 | In distribution | ||
| 288208 | In distribution | ||
| 214113 | In distribution | ||
| 224209 | In distribution | ||
| 288221 | In distribution | ||
| 214502 | In distribution | ||
| 219973 | In distribution | ||
| 219952 | In distribution | ||
| 214121 | In distribution | ||
| 698345167 | In distribution | ||
| 214015 | In distribution | ||
| 211311 | In distribution | ||
| 214105 | In distribution | ||
| 292959001 | In distribution | ||
| 214109 | In distribution | ||
| 219434 | In distribution | ||
| 288239 | In distribution | ||
| 219215 | In distribution | ||
| 270120 | 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.