Ligafix
Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the LIGAFIX interference screw for ACL reconstruction (Outside-In…
Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the LIGAFIX interference screw for ACL reconstruction (Outside-In and Blind Tunnel techniques).
53manufacturers in China registered for this device type
56catalogue 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 | S.B.M |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2023-09-25 |
| Record revised | 2024-09-11 (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, manufacturing date |
| Sizes | Outer diameter 0.8 to 4.5 mm; length 300 to 400 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Guide pin introducer for rigid guide pin Ø 0.9 mm | In distribution | |
| Super elastic guide pin X5 | Outer Diameter 0.8 mm | In distribution |
| Super elastic guide pin X10 | Outer Diameter 0.8 mm | In distribution |
| Guide pin (K-wire) Ø 2.5 mm – L 300 mm | In distribution | |
| Guide pin (K-wire) Ø 2.5 mm – L 300 mm | In distribution | |
| Rigid guide pin X10 | Outer Diameter 1.4 mm | In distribution |
| Guide pin (K-wire) Ø 2.5 mm – L 300 mm | In distribution | |
| Rigid guide pin X10 | Outer Diameter 0.9 mm | In distribution |
| Super elastic guide pin X1 | Outer Diameter 0.8 mm | In distribution |
| LIGAFIX complete Outside Inside & Blind Tunnel instrumentation set (USA) | In distribution | |
| Guide pin (K-wire) Ø 2.5 mm – L 300 mm | In distribution | |
| SN-SBM open stripper | In distribution | |
| LIGAFIX Stopper | In distribution | |
| Super elastic guide pin X10 | Outer Diameter 1.4 mm | In distribution |
| Drill guide | Outer Diameter 4.5 mm | In distribution |
| Pistol-grip femoral aiming device Ø 9 mm | In distribution | |
| LIGAFIX diameter 2.5 mm drill guide | In distribution | |
| Pistol-grip femoral aiming device Ø 10 mm | In distribution | |
| Pin Set | In distribution | |
| Super elastic guide pin X1 | Outer Diameter 1.4 mm | In distribution |
| LIGAFIX evolution femoral outside-In aiming device | In distribution | |
| Rigid guide pin X1 | Outer Diameter 1.1 mm | In distribution |
| Rigid guide pin X5 | Outer Diameter 1.4 mm | In distribution |
| Guide pin (K-wire) Ø 2.5 mm – L 300 mm | In distribution | |
| LIGAFIX complete Outside-In instrumentation set – | In distribution | |
| LIGAFIX complete Blind Tunnel instrumentation set | In distribution | |
| Rigid guide pin X5 | Outer Diameter 0.9 mm | In distribution |
| Rigid guide pin X10 | Outer Diameter 0.9 mm | In distribution |
| Super elastic guide pin X5 | Outer Diameter 1.4 mm | In distribution |
| Super elastic guide pin X5 | Outer Diameter 0.8 mm | In distribution |
| Super elastic guide pin X10 | Outer Diameter 0.8 mm | In distribution |
| Pin Set | In distribution | |
| Conical stopper | In distribution | |
| Super elastic guide pin X10 | Outer Diameter 1.4 mm | In distribution |
| Lanceolate eyelet pin X5 | Outer Diameter 2.5 mm | In distribution |
| Super elastic guide pin X1 | Outer Diameter 1.4 mm | In distribution |
| Rigid guide pin X1 | Outer Diameter 0.9 mm | In distribution |
| LIGAFIX Graft gauge – half sizes | In distribution | |
| Chondral pick | In distribution | |
| Rigid guide pin X5 | Outer Diameter 1.1 mm | In distribution |
| Rigid guide pin X1 | Outer Diameter 1.4 mm | In distribution |
| Rigid guide pin X5 | Outer Diameter 0.9 mm | In distribution |
| Guide pin (K-wire) Ø 2.5 mm – L 300 mm | In distribution | |
| Rigid guide pin X10 | Outer Diameter 1.4 mm | In distribution |
| LIGAFIX guide pin sleeve for evolution femoral outside-in aiming device | In distribution | |
| Rigid guide pin X1 | Outer Diameter 0.9 mm | In distribution |
| LIGAFIX ratchet screwdriver handle | In distribution | |
| Rigid guide pin X10 | Outer Diameter 1.1 mm | In distribution |
| Super elastic guide pin X1 | Outer Diameter 0.8 mm | In distribution |
| Rigid guide pin X5 | Outer Diameter 1.4 mm | In distribution |
| Super elastic guide pin X5 | Outer Diameter 1.4 mm | In distribution |
| Lanceolate eyelet pin X1 | Outer Diameter 2.5 mm | In distribution |
| LIGAFIX tibial aiming device-evolution | In distribution | |
| Rigid guide pin X1 | Outer Diameter 1.4 mm | In distribution |
| Lanceolate eyelet pin X10 | Outer Diameter 2.5 mm | In distribution |
| SBM closed stripper | 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.