Universal 2™ Total Wrist Implant System
Universal 2™ Total Wrist Implant System T-HANDLE RADIAL TRIAL REMOVER
53manufacturers in China registered for this device type
33catalogue 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 | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-03-09 |
| Record revised | 2023-05-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 268706 | 69mm Length x 6.0mm Diameter | In distribution |
| 266300 | 16.50mm Length x 12.7mm Width x 39.50mm Height | In distribution |
| 265400 | 18.20mm Length x 28.02mm Width x 42.70mm Height | In distribution |
| 266100 | 13.30mm Length x 10.3mm Width x 32.20mm Height | In distribution |
| 266302 | 16.50mm Length x 17.7mm Width x 39.50mm Height | In distribution |
| 266201 | 14.90mm Length x 14.4mm Width x 35.70mm Height | In distribution |
| 266401 | 18.30mm Length x 18.75mm Width x 43.70mm Height | In distribution |
| 266102 | 13.30mm Length x 15.3mm Width x 32.20mm Height | In distribution |
| 267300LF | 16.70mm Length x 49.8mm Width 34.0mm Height | In distribution |
| 267300RT | 16.70mm Length x 49.8mm Width 34.0mm Height | In distribution |
| 268725 | 100mm Length x 5.00mm Diameter | In distribution |
| 266402 | 18.30mm Length x 21.25mm Width x 43.70mm Height | In distribution |
| 266101 | 13.30mm Length x 12.8mm Width x 32.20mm Height | In distribution |
| 268610 | 130mm Length x 50mm Width x 12mm Height | In distribution |
| 267400RT | 18.55mm Length x 54.8mm Width 37.2mm Height | In distribution |
| 265100 | 13.20mm Length x 23.46mm Width x 31.20mm Height | In distribution |
| 268114 | 150mm Length x 1.40mm Diameter | In distribution |
| 268510 | In distribution | |
| 266301 | 16.50mm Length x 15.2mm Width x 39.50mm Height | In distribution |
| 267400LF | 18.55mm Length x 54.8mm Width 37.2mm Height | In distribution |
| 265200 | 14.80mm Length x 24.02mm Width x 34.70mm Height | In distribution |
| 268700 | 116mm Length x 20mm Diameter | In distribution |
| 267200RT | 15.00mm Length x 45.0mm Width 31.2mm Height | In distribution |
| 267200LF | 15.00mm Length x 45.0mm Width 31.2mm Height | In distribution |
| 266202 | 14.90mm Length x 16.9mm Width x 35.70mm Height | In distribution |
| 267100RT | 13.50mm Length x 40.3mm Width 28.1mm Height | In distribution |
| 265300 | 16.40mm Length x 26.02mm Width x 38.50mm Height | In distribution |
| 266400 | 18.30mm Length x 16.25mm Width x 43.70mm Height | In distribution |
| 268111 | 100mm Length x 1.10mm Diameter | In distribution |
| 267100LF | 13.50mm Length x 40.3mm Width 28.1mm Height | In distribution |
| 266200 | 14.90mm Length x 11.9mm Width x 35.70mm Height | In distribution |
| 268517 | 7.0mm Length x 7.9mm Diameter | Withdrawn |
| 268516 | 29.7mm Length x 7.9mm Diameter | Withdrawn |
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.