Klassic BiPolar Trial
BiPolar Trial, 39mm OD, 22mm Head, Locking
53manufacturers in China registered for this device type
46catalogue 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 | Total Joint Orthopedics, 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, Complaint-file establishment, Manufacturer |
| Record published | 2019-10-21 |
| Record revised | 2023-12-12 (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 |
| Storage | Special storage condition: The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1322.58.028 | 58mm OD, 28mm Head | In distribution |
| 1322.50.028 | 50mm OD, 28mm Head | In distribution |
| 1340.39.022 | 39mm OD, 22mm Head | In distribution |
| 1340.50.028 | 50mm OD, 28mm Head | In distribution |
| 1322.54.028 | 54mm OD, 28mm Head | In distribution |
| 1340.46.028 | 46mm OD, 28mm Head | In distribution |
| 1340.40.022 | 40mm OD, 22mm Head | In distribution |
| 1322.47.028 | 47mm OD, 28mm Head | In distribution |
| 1322.51.028 | 51mm OD, 28mm Head | In distribution |
| 1322.38.022 | 38mm OD, 22mm Head | In distribution |
| 1340.60.028 | 60mm OD, 28mm Head | In distribution |
| 1340.44.028 | 44mm OD, 28mm Head | In distribution |
| 1322.53.028 | 53mm OD, 28mm Head | In distribution |
| 1340.49.028 | 49mm OD, 28mm Head | In distribution |
| 1340.57.028 | 57mm OD, 28mm Head | In distribution |
| 1322.42.022 | 42mm OD, 22mm Head | In distribution |
| 1340.42.022 | 42mm OD, 22mm Head | In distribution |
| 1322.40.022 | 40mm OD, 22mm Head | In distribution |
| 1322.39.022 | 39mm OD, 22mm Head | In distribution |
| 1322.49.028 | 49mm OD, 28mm Head | In distribution |
| 1322.44.028 | 44mm OD, 28mm Head | In distribution |
| 1340.52.028 | 52mm OD, 28mm Head | In distribution |
| 1340.55.028 | 55mm OD, 28mm Head | In distribution |
| 1322.56.028 | 56mm OD, 28mm Head | In distribution |
| 1322.45.028 | 45mm OD, 28mm Head | In distribution |
| 1340.51.028 | 51mm OD, 28mm Head | In distribution |
| 1322.55.028 | 55mm OD, 28mm Head | In distribution |
| 1340.56.028 | 56mm OD, 28mm Head | In distribution |
| 1340.54.028 | 54mm OD, 28mm Head | In distribution |
| 1340.53.028 | 53mm OD, 28mm Head | In distribution |
| 1322.41.022 | 41mm OD, 22mm Head | In distribution |
| 1340.45.028 | 45mm OD, 28mm Head | In distribution |
| 1340.59.028 | 59mm OD, 28mm Head | In distribution |
| 1340.48.028 | 48mm OD, 28mm Head | In distribution |
| 1322.59.028 | 59mm OD, 28mm Head | In distribution |
| 1322.52.028 | 52mm OD, 28mm Head | In distribution |
| 1322.46.028 | 46mm OD, 28mm Head | In distribution |
| 1322.60.028 | 60mm OD, 28mm Head | In distribution |
| 1340.43.022 | 43mm OD, 22mm Head | In distribution |
| 1340.47.028 | 47mm OD, 28mm Head | In distribution |
| 1322.43.022 | 43mm OD, 22mm Head | In distribution |
| 1340.41.022 | 41mm OD, 22mm Head | In distribution |
| 1340.58.028 | 58mm OD, 28mm Head | In distribution |
| 1322.48.028 | 48mm OD, 28mm Head | In distribution |
| 1340.38.022 | 38mm OD, 22mm Head | In distribution |
| 1322.57.028 | 57mm OD, 28mm Head | 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.