Monopoly
140 catalogue numbers from T-handle, ratchet, listed by Signus Medizintechnik Gmbh, Germany, under Orthopedic Manual Surgical Instrument. 53 manufacturers in China are registered for this product code.
53manufacturers in China registered for this device type
140catalogue 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 | Signus Medizintechnik Gmbh, Germany |
|---|---|
| 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-06-23 |
| Record revised | 2024-02-07 (version 2) |
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, serial number |
| Storage | Storage environment temperature 0 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T-handle, ratchet | 1/4″ | In distribution |
| Screw plate | Ø7,5x35mm | In distribution |
| Tray, lid | In distribution | |
| Screwdriver, set screw | 1/4″,SW4,5 | In distribution |
| Sleeve, tulip seizer | In distribution | |
| Persuador, mandrel | In distribution | |
| Guide wire, trocar/round | Ø1,7x500mm | In distribution |
| Dilator, inside | In distribution | |
| Screw plate | Ø6,5x35mm | In distribution |
| Screw plate | Ø6,5x50mm | In distribution |
| Awl cannulated | In distribution | |
| Connection fork bolt | In distribution | |
| Sleeve, fixation | MPII | In distribution |
| Tray, lid | In distribution | |
| Phantom rod | 4x400mm | In distribution |
| Screw plate | Ø6,5x60mm | In distribution |
| Sleeve, fixation | In distribution | |
| Disassembly block | In distribution | |
| Reduction tower, inner sleeve | In distribution | |
| Screwdriver, triangle | SW4,5 | In distribution |
| Tray, instruments | In distribution | |
| Tray, implants/instruments | In distribution | |
| Tap cannulated | Ø5mm | In distribution |
| Guide wire, trocar/round | Ø1,8x600mm | In distribution |
| Screwdriver, set screw | starter | In distribution |
| Screwdriver, set screw | 1/4″,SW4,5 | In distribution |
| Dilator chuck, small | In distribution | |
| Dilator, outside | In distribution | |
| Screw plate | Ø4,5x45mm | In distribution |
| Counter-torque, spring | In distribution | |
| Persuador sleeve | In distribution | |
| Dispenser, guide wire | 440mm | In distribution |
| Screw plate | Ø5,5x35mm | In distribution |
| Tray, lid | In distribution | |
| Tray, implants | In distribution | |
| Tray, lid | In distribution | |
| Sleeve, fixation | In distribution | |
| Sleeve, set screw | In distribution | |
| Tap cannulated | Ø6mm | In distribution |
| Pedicle sensor | In distribution | |
| Screwdriver, persuader | In distribution | |
| Tray, instruments | In distribution | |
| Screwdriver, angle cover | In distribution | |
| Screw plate | Ø7,5x55mm | In distribution |
| Rod clamp, fixing device | In distribution | |
| Length indicator, rod | In distribution | |
| Tray, lid | In distribution | |
| Torque limiter | 11Nm,1/4″ | In distribution |
| Tap cannulated | Ø7mm | In distribution |
| Screw plate | Ø6,5x45mm | In distribution |
| Tap cannulated | Ø5mm | In distribution |
| Rod clamp, locking knob | In distribution | |
| Rack, screw plate | In distribution | |
| Screwdriver, core | In distribution | |
| Tap cannulated | Ø4mm | In distribution |
| Screw plate | Ø7,5x45mm | In distribution |
| Length indicator, cross connector | In distribution | |
| Screw plate | Ø5,5x60mm | In distribution |
| Tap cannulated | Ø6mm | In distribution |
| Aiming device arm | In distribution | |
| Tulip seizer | In distribution | |
| Screw plate | Ø4,5x30mm | In distribution |
| Rod clamp | In distribution | |
| Counter-torque, guiding sleeve | In distribution | |
| Screw plate | Ø6,5x55mm | In distribution |
| Screw plate | Ø5,5x30mm | In distribution |
| Guide wire, trocar/round | Ø1,7x500mm | In distribution |
| Tray, lid | In distribution | |
| Assembly block | In distribution | |
| Tray, instruments | In distribution | |
| Tray, instruments | In distribution | |
| Reduction tower, set screw | In distribution | |
| Counter-torque, nut | In distribution | |
| Screw plate | Ø5,5x55mm | In distribution |
| Screwdriver, blade | In distribution | |
| Tap cannulated | Ø5mm | In distribution |
| Guide wire, trocar/round | Ø1,8x500mm | In distribution |
| Counter-torque, tower | In distribution | |
| Screw plate | Ø6,5x65mm | In distribution |
| Rod clamp | In distribution | |
| Screw plate | Ø7,5x50mm | In distribution |
| Aiming device bolt | In distribution | |
| Screw plate | Ø4,5x35mm | In distribution |
| Guide wire, trocar/round | Ø1,8x500mm | In distribution |
| Dilator chuck, large | In distribution | |
| Sleeve, fixation | In distribution | |
| Rod clamp | part 2 | In distribution |
| Screw plate | Ø7,5x30mm | In distribution |
| Screw plate | Ø7,5x60mm | In distribution |
| Screw plate | Ø5,5x40mm | In distribution |
| Tap cannulated | Ø7mm | In distribution |
| Screw plate | Ø4,5x55mm | In distribution |
| Positioner, screws | In distribution | |
| Mandrel, rod clamp | In distribution | |
| Screw plate | Ø4,5x50mm | In distribution |
| Sleeve, fixation | In distribution | |
| Tower adjuster | In distribution | |
| Screw plate | Ø7,5x40mm | In distribution |
| Length indicator, ruler | In distribution | |
| Tray, implants | In distribution | |
| Torque limiter | triangle,11Nm | In distribution |
| Tap cannulated | Ø7mm | In distribution |
| Rod clamp, tower | In distribution | |
| Counter-torque | In distribution | |
| Guide wire, trocar/round | Ø1,7x500mm | In distribution |
| Rod clamp | part 1 | In distribution |
| Guide wire, trocar/round | Ø1,8x500mm | In distribution |
| Assembly core | In distribution | |
| Screwdriver monoaxial | In distribution | |
| Guide wire, round/round | Ø1,6x500mm | In distribution |
| Sleeve, cement delivery | MPII | In distribution |
| Screw plate | Ø5,5x45mm | In distribution |
| Tray, implants, lid | In distribution | |
| Screw plate | Ø4,5x40mm | In distribution |
| Guide wire, trocar/round | Ø1,6x500mm | In distribution |
| Counter-torque, handle | In distribution | |
| Dispenser, guide wire | 440mm | In distribution |
| Rod clamp, handle locking device | In distribution | |
| Tray, implants | In distribution | |
| Screw plate | Ø6,5x30mm | In distribution |
| Tray, instruments | In distribution | |
| Reduction tower, outer sleeve | In distribution | |
| Screwdriver, set screw, mandrel | In distribution | |
| Screwdriver | In distribution | |
| Guide wire, trocar/round | Ø1,8x600mm | In distribution |
| Guide wire, trocar/round | Ø1,6x500mm | In distribution |
| Dissassembly core, large | In distribution | |
| Screw plate | Ø6,5x40mm | In distribution |
| Screw plate | Ø5,5x50mm | In distribution |
| Counter-torque, reduction tower | In distribution | |
| Tulip adjuster | In distribution | |
| Tap cannulated | Ø6mm | In distribution |
| Guide wire, trocar/round | Ø1,6x500mm | In distribution |
| Guide wire, round/round | Ø1,8x500mm | In distribution |
| Rod gauge | In distribution | |
| Outer tower | In distribution | |
| Handle, tower | In distribution | |
| Phantom rod | 4x150mm | In distribution |
| Reduction tower, rotary knob | In distribution | |
| Rod clamp, mandrel | 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.