Autobahn
AUTOBAHN CoCr Headless Locking Screw, 4mmx77.5mm, Partially Threaded
17manufacturers in China registered for this device type
1,258catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 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 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K171108 |
| Record published | 2019-07-23 |
| Record revised | 2025-02-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 5 to 500 mm; outer diameter 4 to 15 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1190.2150S | Length 500 mm | In distribution |
| 1183.2035S | Fully Threaded | In distribution |
| 1183.1030S | Outer Diameter 10 mm | In distribution |
| 1190.5105S | Outer Diameter 6.5 mm | In distribution |
| 1183.7065S | Outer Diameter 5 mm | In distribution |
| 1183.0128S | Partially Threaded | In distribution |
| 7183.6020 | Length 20 mm | In distribution |
| 1190.3022S | Length 220 mm | In distribution |
| 7183.0068 | Partially Threaded | In distribution |
| 1183.1830S | Outer Diameter 8 mm | In distribution |
| 1190.2249S | Outer Diameter 12 mm | In distribution |
| 1190.1228S | Length 280 mm | In distribution |
| 7183.4100 | Fully Threaded | In distribution |
| 1190.1524S | Length 240 mm | In distribution |
| 1257.2038S | In distribution | |
| 7183.5033S | Length 32.5 mm | In distribution |
| 1183.1227 | Length 270 mm | In distribution |
| 1183.1822 | Outer Diameter 8 mm | In distribution |
| 7183.2055S | Length 55 mm | In distribution |
| 1190.1318S | Length 180 mm | In distribution |
| 1190.2546S | Entry, GT | In distribution |
| 7183.6103 | Length 102.5 mm | In distribution |
| 7183.4050 | Outer Diameter 4 mm | In distribution |
| 7183.6053 | Partially Threaded | In distribution |
| 1183.3095S | Length 95 mm | In distribution |
| 1183.1248S | Outer Diameter 12 mm | In distribution |
| 1183.7035 | Length 35 mm | In distribution |
| 1257.3132S | In distribution | |
| 1257.1036S | In distribution | |
| 1183.5048S | Outer Diameter 5 mm | In distribution |
| 7183.2095 | Fully Threaded | In distribution |
| 1190.3146S | Entry, PF | In distribution |
| 1190.2935S | Outer Diameter 9 mm | In distribution |
| 1183.0085S | Length 85 mm | In distribution |
| 1190.3432S | Outer Diameter 14 mm | In distribution |
| 1183.1142S | Length 420 mm | In distribution |
| 1190.2440S | Right | In distribution |
| 1190.3028S | Length 280 mm | In distribution |
| 1183.4118 | Outer Diameter 4 mm | In distribution |
| 1183.0065 | Partially Threaded | In distribution |
| 1183.6115S | Length 115 mm | In distribution |
| 1183.6023 | Partially Threaded | In distribution |
| 7183.0053 | Outer Diameter 4 mm | In distribution |
| 7183.6058S | Partially Threaded | In distribution |
| 1176.5126S | Degree, 130° | In distribution |
| 1190.1017S | Outer Diameter 10 mm | In distribution |
| 1183.3048 | Length 47.5 mm | In distribution |
| 1190.6105S | Partially Threaded | In distribution |
| 5183.1949 | Length 495 mm | In distribution |
| 1176.0110S | Length 110 mm | In distribution |
| 5183.1522S | Outer Diameter 15 mm | In distribution |
| 7183.8108S | Length 107.5 mm | In distribution |
| 1183.2048 | Fully Threaded | In distribution |
| 1183.7043S | Partially Threaded | In distribution |
| 1190.7053S | Length 52.5 mm | In distribution |
| 1183.5025 | Length 25 mm | In distribution |
| 1190.1019S | Left | In distribution |
| 1190.2221S | Entry, GT | In distribution |
| 1190.1346S | Outer Diameter 13 mm | In distribution |
| 7183.6098S | Partially Threaded | In distribution |
| 1257.8335S | In distribution | |
| 1183.0028 | Length 27.5 mm | In distribution |
| 1183.4118S | Outer Diameter 4 mm | In distribution |
| 7183.0123S | Partially Threaded | In distribution |
| 6257.1003 | In distribution | |
| 5183.1033S | Outer Diameter 10 mm | In distribution |
| 5183.1827S | Length 270 mm | In distribution |
| 1183.4065S | Length 65 mm | In distribution |
| 1176.6940S | In distribution | |
| 1183.4060S | Outer Diameter 4 mm | In distribution |
| 1183.1219S | Length 195 mm | In distribution |
| 1176.6234S | Length 340 mm | In distribution |
| 5183.1319 | Length 195 mm | In distribution |
| 7183.0085 | Length 85 mm | In distribution |
| 1190.3133S | Length 330 mm | In distribution |
| 1176.4240S | Right | In distribution |
| 1190.3931S | Entry, PF | In distribution |
| 7183.7030 | Length 30 mm | In distribution |
| 1190.1146S | Entry, GT | In distribution |
| 1190.2348S | Entry, GT | In distribution |
| 7183.8088 | Length 87.5 mm | In distribution |
| 1190.1249S | Entry, GT | In distribution |
| 7183.0130S | Partially Threaded | In distribution |
| 7183.7128S | Partially Threaded | In distribution |
| 1257.6040S | In distribution | |
| 1257.8580 | In distribution | |
| 1190.2125S | Right | In distribution |
| 7183.2080 | Length 80 mm | In distribution |
| 7183.2130 | Outer Diameter 5 mm | In distribution |
| 5183.1142S | Outer Diameter 11 mm | In distribution |
| 1190.2425S | Length 250 mm | In distribution |
| 7183.5110S | Outer Diameter 5 mm | In distribution |
| 1183.5120 | Outer Diameter 5 mm | In distribution |
| 1183.3068S | Length 67.5 mm | In distribution |
| 1183.1842S | Outer Diameter 8 mm | In distribution |
| 5183.1236S | Length 360 mm | In distribution |
| 1183.1827 | Length 270 mm | In distribution |
| 6190.1031 | In distribution | |
| 1183.2108 | Fully Threaded | In distribution |
| 1183.6103 | Outer Diameter 4 mm | In distribution |
| 1183.1318S | Length 180 mm | In distribution |
| 1257.4044S | In distribution | |
| 1183.0073 | Partially Threaded | In distribution |
| 7183.0025 | Outer Diameter 4 mm | In distribution |
| 1183.0130 | Partially Threaded | In distribution |
| 5183.1143S | Outer Diameter 11 mm | In distribution |
| 1183.8023 | Length 22.5 mm | In distribution |
| 1257.4136S | In distribution | |
| 1257.1038S | In distribution | |
| 7183.6090S | Outer Diameter 4 mm | In distribution |
| 1190.2244S | Outer Diameter 12 mm | In distribution |
| 5183.1442 | Length 420 mm | In distribution |
| 1183.2023S | Outer Diameter 5 mm | In distribution |
| 1190.9820 | In distribution | |
| 1183.6128 | Length 127.5 mm | In distribution |
| 1190.3427S | Entry, PF | In distribution |
| 1190.1950S | Entry, GT | In distribution |
| 7183.3038S | Outer Diameter 5 mm | In distribution |
| 1183.3020 | Outer Diameter 5 mm | In distribution |
| 1190.2147S | Entry, GT | In distribution |
| 1183.1245 | Outer Diameter 12 mm | In distribution |
| 1183.1845 | Outer Diameter 8 mm | In distribution |
| 7183.5090 | Outer Diameter 5 mm | In distribution |
| 1257.4238S | In distribution | |
| 1190.1519S | Entry, GT | In distribution |
| 1183.8083S | Outer Diameter 4 mm | In distribution |
| 1183.1448S | Outer Diameter 14 mm | In distribution |
| 1190.7095 | In distribution | |
| 1183.1324S | Outer Diameter 13 mm | In distribution |
| 5183.1028S | Length 285 mm | In distribution |
| 1183.3103S | Outer Diameter 5 mm | In distribution |
| 1183.7125 | Outer Diameter 5 mm | In distribution |
| 1183.1921S | Outer Diameter 9 mm | In distribution |
| 7183.3098S | Outer Diameter 5 mm | In distribution |
| 7183.4083S | Fully Threaded | In distribution |
| 5183.1345S | Length 450 mm | In distribution |
| 1190.7120S | Length 120 mm | In distribution |
| 1176.5040S | Outer Diameter 10 mm | In distribution |
| 7183.3068 | Length 67.5 mm | In distribution |
| 1183.6105S | Outer Diameter 4 mm | In distribution |
| 7183.3025 | Partially Threaded | In distribution |
| 1183.6058 | Outer Diameter 4 mm | In distribution |
| 1176.9312S | In distribution | |
| 1183.1233 | Length 330 mm | In distribution |
| 5183.1333S | Outer Diameter 13 mm | In distribution |
| 1183.1342 | Outer Diameter 13 mm | In distribution |
| 6183.1017 | In distribution | |
| 5183.1948 | Outer Diameter 9 mm | In distribution |
| 1257.8590S | In distribution | |
| 1190.5130 | In distribution | |
| 1183.1216 | Outer Diameter 12 mm | In distribution |
| 1183.2070 | Outer Diameter 5 mm | In distribution |
| 1183.1933S | Outer Diameter 9 mm | In distribution |
| 1183.1328 | Length 285 mm | In distribution |
| 7183.7078S | Partially Threaded | In distribution |
| 5183.1927 | Outer Diameter 9 mm | In distribution |
| 1183.1345S | Outer Diameter 13 mm | In distribution |
| 1183.4048 | Outer Diameter 4 mm | In distribution |
| 1183.2020 | Length 20 mm | In distribution |
| 5183.1927S | Length 270 mm | In distribution |
| 7183.3030S | Partially Threaded | In distribution |
| 1190.1924S | Outer Diameter 9 mm | In distribution |
| 1190.1034S | Entry, GT | In distribution |
| 1257.8400 | In distribution | |
| 7183.8093 | Length 92.5 mm | In distribution |
| 1183.1427 | Outer Diameter 14 mm | In distribution |
| 1183.1916S | Outer Diameter 9 mm | In distribution |
| 1183.3113 | Length 112.5 mm | In distribution |
| 1183.1225 | Outer Diameter 12 mm | In distribution |
| 1183.1821 | Outer Diameter 8 mm | In distribution |
| 7183.5073S | Outer Diameter 5 mm | In distribution |
| 5183.1131S | Length 315 mm | In distribution |
| 7183.8023S | Length 22.5 mm | In distribution |
| 7183.7113 | Outer Diameter 5 mm | In distribution |
| 1183.8118S | Length 117.5 mm | In distribution |
| 1183.2120 | Fully Threaded | In distribution |
| 1183.1922 | Length 225 mm | In distribution |
| 7183.4053 | Fully Threaded | In distribution |
| 1183.1548 | Length 480 mm | In distribution |
| 5183.1931S | Length 315 mm | In distribution |
| 1257.8335 | In distribution | |
| 1190.2436S | Length 360 mm | In distribution |
| 1190.2029S | Length 290 mm | In distribution |
| 1190.6138S | Outer Diameter 6.5 mm | In distribution |
| 1190.2227S | Entry, GT | In distribution |
| 1183.7073S | Outer Diameter 5 mm | In distribution |
| 5183.1339 | Outer Diameter 13 mm | In distribution |
| 1183.1330 | Length 300 mm | In distribution |
| 1183.7125S | Outer Diameter 5 mm | In distribution |
| 1190.2950S | Right | In distribution |
| 1183.3093S | Length 92.5 mm | In distribution |
| 7183.6020S | Length 20 mm | In distribution |
| 1190.2140S | Entry, GT | In distribution |
| 7183.5120 | Outer Diameter 5 mm | In distribution |
| 1183.8103 | Fully Threaded | In distribution |
| 1183.3060 | Partially Threaded | In distribution |
| 5183.1030 | Length 300 mm | In distribution |
| 1190.3121S | Outer Diameter 11 mm | In distribution |
| 7183.7025 | Outer Diameter 5 mm | In distribution |
| 7183.4085 | Fully Threaded | In distribution |
| 1183.0085 | Partially Threaded | In distribution |
| 1183.7053S | Outer Diameter 5 mm | In distribution |
| 7183.6058 | Length 57.5 mm | In distribution |
| 1190.2217S | Outer Diameter 12 mm | In distribution |
| 1190.1032S | Outer Diameter 10 mm | In distribution |
| 7183.8020S | Outer Diameter 4 mm | In distribution |
| 1190.2937S | Right | In distribution |
| 1183.1549S | Outer Diameter 15 mm | In distribution |
| 1190.3032S | Entry, PF | In distribution |
| 1190.2447S | Right | In distribution |
| 1183.1340 | Length 405 mm | In distribution |
| 1183.2050 | Outer Diameter 5 mm | In distribution |
| 1183.8088S | Fully Threaded | In distribution |
| 7183.7063S | Partially Threaded | In distribution |
| 5183.1037 | Length 375 mm | In distribution |
| 1190.5100S | Fully Threaded | In distribution |
| 1183.1918S | Outer Diameter 9 mm | In distribution |
| 7183.7085 | Outer Diameter 5 mm | In distribution |
| 1183.6063 | Length 62.5 mm | In distribution |
| 1183.1034S | Outer Diameter 10 mm | In distribution |
| 1183.1131 | Length 315 mm | In distribution |
| 1183.0065S | Outer Diameter 4 mm | In distribution |
| 1183.1446S | Length 465 mm | In distribution |
| 1183.8080S | Outer Diameter 4 mm | In distribution |
| 1183.1146S | Outer Diameter 11 mm | In distribution |
| 7183.6125 | Length 125 mm | In distribution |
| 1190.3030S | Length 300 mm | In distribution |
| 1183.5095S | Outer Diameter 5 mm | In distribution |
| 1190.6130S | Outer Diameter 6.5 mm | In distribution |
| 1257.5038S | In distribution | |
| 7183.8100 | Fully Threaded | In distribution |
| 1183.9815S | In distribution | |
| 1183.5123S | Outer Diameter 5 mm | In distribution |
| 1176.4138S | Right | In distribution |
| 1176.6146S | Right | In distribution |
| 7183.4118 | Outer Diameter 4 mm | In distribution |
| 1183.1145S | Outer Diameter 11 mm | In distribution |
| 1183.1222 | Length 225 mm | In distribution |
| 1183.1818 | Outer Diameter 8 mm | In distribution |
| 1257.5142S | In distribution | |
| 1183.1327 | Outer Diameter 13 mm | In distribution |
| 1190.2419S | Length 190 mm | In distribution |
| 1183.1221S | Length 210 mm | In distribution |
| 1183.4088 | Length 87.5 mm | In distribution |
| 5183.1943 | Length 435 mm | In distribution |
| 1183.8078 | Length 77.5 mm | In distribution |
| 1183.6123 | Length 122.5 mm | In distribution |
| 1190.2536S | Length 360 mm | In distribution |
| 7183.3083S | Outer Diameter 5 mm | In distribution |
| 1190.1436S | Outer Diameter 14 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
| Precice® Bone Transport System | NuVasive Specialized Orthopedics, Inc. | 546 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261043 | 2026-04-24 |
| K220659 | 2022-09-09 |
| K171108 | 2017-12-29 |
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.