GSO GS1 Spinal System
3.5mm Hex Bit - 1/4" Drive for Cannulated Screws
53manufacturers in China registered for this device type
60catalogue 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 | Unified Spine, 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, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-21 |
| Record revised | 2024-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 504208 | Rod Compressor | In distribution |
| 508152 | Anti-Torque Device | In distribution |
| 508211 | Rod Holder Fixed | In distribution |
| 504126 | 10-12mm Dilator | In distribution |
| 504211 | Rod Holder | In distribution |
| 504124 | 8-10mm Dilator | In distribution |
| 504148 | 15mm Shaver | In distribution |
| 504125 | 8-10mm Dilator | In distribution |
| 508208 | Compressor Separation Instrument | In distribution |
| 504128 | Head Aligner | In distribution |
| 504151 | Poly-Axial Inserter Screw Driver | In distribution |
| 50715514 | 14mm Drill Guide Extension | In distribution |
| 504165 | Locking Screw Inserter Assembly | In distribution |
| 504171 | Hook Holder | In distribution |
| 504134 | Spacer Grasper | In distribution |
| 508154 | 3.5mm Hex Bit – 1/4″ Drive for Cannulated Screws | In distribution |
| 504132 | Spacer Remover | In distribution |
| 504105 | Set Screw Starter | In distribution |
| 504102 | Anti-Torque Device | In distribution |
| 508245 | Access Instrument Trocar | In distribution |
| 504130 | Spacer Positioner | In distribution |
| 504142 | 9mm Shaver | In distribution |
| 504140 | 7mm Shaver | In distribution |
| 504155 | Set Screw Starter | In distribution |
| 504137 | Non-Ratcheting T-Handle w/1/4″ SQ QC | In distribution |
| 504112 | Mechanical Reducer | In distribution |
| 504114 | Mechanical Reducer | In distribution |
| 508241 | T-handle for Access Tool | In distribution |
| 504104 | Torque Limiting 3.5mm Hex Bit | In distribution |
| 504110 | Ratchet QC Driver for Poly-Axial Screw Inst | In distribution |
| 504107 | 3/8″ Nut Driver | In distribution |
| 508155 | Set Screw Starter | In distribution |
| 508207 | Distractor | In distribution |
| 508151 | Inserter | In distribution |
| 504147 | 14mm Shaver | In distribution |
| 504209 | Rod Reducer | In distribution |
| 508220 | Palm Handle Ratchet with 1/4″ Square Drive | In distribution |
| 504103 | Torque Limiting Driver Handle | In distribution |
| 504106 | 3.5mm Hex Driver | In distribution |
| 508115 | Cannula / Dilator Set | In distribution |
| 508116 | Ring Breaker | In distribution |
| 504163 | Navigation Screw Inserter Assembly | In distribution |
| 508212 | Rod Holder Hex Driver | In distribution |
| 504154 | 3.5mm Hex Bit – 1/4″ Drive | In distribution |
| 504141 | 8mm Shaver | In distribution |
| 504161 | Multi-Axial Screw Inserter With Nut | In distribution |
| 504108 | Mechanical Rod Reducer | In distribution |
| 504144 | 11mm Shaver | In distribution |
| 504143 | 10mm Shaver | In distribution |
| 504129 | Head Aligner | In distribution |
| 504145 | 12mm Shaver | In distribution |
| 504207 | Rod Distractor | In distribution |
| 504210 | Rod Gripper | In distribution |
| 504135 | Set Screw Starter Assembly (New) | In distribution |
| 504152 | Anti-Torque Device | In distribution |
| 504120 | Driver Sleeve | In distribution |
| 504146 | 13mm Shaver | In distribution |
| 508206 | 3.5mm Hex Driver w/ Collar | In distribution |
| 508153 | Anti-Torque Device | In distribution |
| 504172 | Hook Grasper | 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.