Conmed
Extended Length Modular TRI-Lobe Driver FOR 5.0 MM Interference Screws, 8.4"
53manufacturers in China registered for this device type
71catalogue numbers in this listing
4recalls on this code
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 | ConMed Corporation, United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2024-08-19 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: KEEP DRY |
| Packaging | Box, carton |
| Sizes | Angle 15 to 90 °; length 3.5 to 170 mm; width 2.75 to 3.4 mm; outer diameter 1.5 to 10.5 mm; lumen/inner diameter 6.5 mm |
| Distribution end date | 2023-07-18 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8791 | Outer Diameter 7.5 mm | In distribution | |
| 7204 | Angle 90 ° | In distribution | |
| AA1520-07 | Outer Diameter 1.5 mm | 2 | In distribution |
| 8608 | Length 3.5 mm | In distribution | |
| 97.14115 | Angle 45 ° | In distribution | |
| 1.12211 | Length 130 mm | In distribution | |
| C-GS10D | In distribution | ||
| C-GS020 | In distribution | ||
| C-GS011 | In distribution | ||
| C-GS10R | In distribution | ||
| 9892 | 6 | In distribution | |
| C-GS10C | In distribution | ||
| DFS70 | In distribution | ||
| 97.10215 | Width 3.4 mm | In distribution | |
| MFX-30HV | Angle 30 ° | In distribution | |
| D8651 | 6.2 INCH | In distribution | |
| C-GS24P | In distribution | ||
| C-GS010 | In distribution | ||
| D8660 | 8.4 INCH | In distribution | |
| 97.14215 | Width 3.4 mm | In distribution | |
| 8792 | Outer Diameter 8.5 mm | In distribution | |
| 8202 | Angle 45 ° | In distribution | |
| 7202 | Angle 45 ° | In distribution | |
| 8794 | Outer Diameter 10.5 mm | In distribution | |
| 1.10011 | Width 3.4 mm | In distribution | |
| 9828 | Length 75 mm | In distribution | |
| MFX-0LT | In distribution | ||
| DMS70 | In distribution | ||
| D8650 | 6.2 INCH | In distribution | |
| 7201 | Angle 30 ° | In distribution | |
| C8741 | Length 20 mm | In distribution | |
| C7395 | Outer Diameter 8 mm | In distribution | |
| 9742D | 5 | In distribution | |
| MFX-0HV | In distribution | ||
| D8653 | 6.2 INCH | In distribution | |
| HDL-CLT | In distribution | ||
| C-GS24D | In distribution | ||
| C8740 | Outer Diameter 3 mm | In distribution | |
| 8790 | In distribution | ||
| 8750 | In distribution | ||
| MFX-30ANG | In distribution | ||
| MFX-30LT | Angle 30 ° | In distribution | |
| 8793 | Outer Diameter 9.5 mm | In distribution | |
| C-GS012 | In distribution | ||
| 97.19215 | Angle 90 ° | In distribution | |
| 9894 | 6 | In distribution | |
| 8201 | Angle 30 ° | In distribution | |
| 9893 | 6 | In distribution | |
| C7322 | 6 | In distribution | |
| GU2006EL | In distribution | ||
| 8204 | Angle 90 ° | In distribution | |
| 2.16311 | Angle 15 ° | In distribution | |
| 97.10115 | Width 3.4 mm | In distribution | |
| 1.10012 | Width 3.4 mm | In distribution | |
| GU1005 | Outer Diameter 3.4 mm | In distribution | |
| 97.10015 | Length 130 mm | In distribution | |
| 8730 | In distribution | ||
| MFX-45HV | Angle 45 ° | In distribution | |
| 8748EL | In distribution | ||
| 1.12111 | Length 130 mm | In distribution | |
| C-GS10G | In distribution | ||
| MFX-90LT | In distribution | ||
| MFX-90HV | Angle 90 ° | In distribution | |
| 8203 | Angle 45 ° | In distribution | |
| 97.19115 | Angle 90 ° | In distribution | |
| D8652 | 6.2 INCH | In distribution | |
| C8742 | Outer Diameter 6 mm | In distribution | |
| MFX-45LT | Angle 45 ° | In distribution | |
| 2.10011 | Length 130 mm | In distribution | |
| TS8865 | DIAMETER 6.5 MM | In distribution | |
| C8678 | 2.4 MM AND 343 MM (13.5″) | 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
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-03-26 | Class II | Process control | Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used | 2 units | 2024-04-05 |
| 2021-03-26 | Class II | Process control | Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used | 3 units | 2024-04-05 |
| 2020-11-12 | Class II | Process control | Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system | 95 total: 20 units US and 75 units OUS | 2024-04-05 |
| 2020-11-12 | Class II | Process control | Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system | 73 total: 23 units US;50 units OUS | 2024-04-05 |
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.