T2 Alpha
Poller Screw Inserter, Fixation Screw
31manufacturers in China registered for this device type
163catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-10-30 |
| Record revised | 2025-04-14 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 25 to 480 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2335-1130S | Length 300.0 mm | In distribution |
| 2335-1046S | Length 460.0 mm | In distribution |
| 2337-0944S | Diameter: 9.0 Millimeter | In distribution |
| 2337-1324S | Length 240.0 mm | In distribution |
| 2335-1442S | Length 420.0 mm | In distribution |
| 2360-5120S | Diameter: 5.0 Millimeter | In distribution |
| 2360-5105S | Length 105.0 mm | In distribution |
| 2360-5085S | Diameter: 5.0 Millimeter | In distribution |
| 2335-1532S | Diameter: 15.0 Millimeter | In distribution |
| 2335-1042S | Diameter: 10.0 Millimeter | In distribution |
| 2337-1248S | Diameter: 12.0 Millimeter | In distribution |
| 2335-1448S | Diameter: 14.0 Millimeter | In distribution |
| 2360-5065S | Length 65.0 mm | In distribution |
| 2360-5035S | Length 35.0 mm | In distribution |
| 2337-1436S | Length 360.0 mm | In distribution |
| 2337-1238S | Diameter: 12.0 Millimeter | In distribution |
| 2353-4103 | In distribution | |
| 2335-0944S | Diameter: 9.0 Millimeter | In distribution |
| 2353-4113 | In distribution | |
| 2335-1234S | Diameter: 12.0 Millimeter | In distribution |
| 2353-3503 | In distribution | |
| 2337-1328S | Diameter: 13.0 Millimeter | In distribution |
| 2335-0938S | Length 380.0 mm | In distribution |
| 2335-1242S | Length 420.0 mm | In distribution |
| 2335-1132S | Length 320.0 mm | In distribution |
| 2335-1424S | Length 240.0 mm | In distribution |
| 2335-1338S | Length 380.0 mm | In distribution |
| 2360-5060S | Length 60.0 mm | In distribution |
| 2335-0948S | Length 480.0 mm | In distribution |
| 2335-1430S | Diameter: 14.0 Millimeter | In distribution |
| 2360-5042S | Length 42.5 mm | In distribution |
| 2337-1026S | Diameter: 10.0 Millimeter | In distribution |
| 2353-3301 | In distribution | |
| 2353-3910 | In distribution | |
| 2337-1346S | Length 460.0 mm | In distribution |
| 2360-5090S | Length 90.0 mm | In distribution |
| 2335-1144S | Length 440.0 mm | In distribution |
| 2337-1344S | Length 440.0 mm | In distribution |
| 2337-1532S | Length 320.0 mm | In distribution |
| 2335-0946S | Diameter: 9.0 Millimeter | In distribution |
| 2360-5110S | Diameter: 5.0 Millimeter | In distribution |
| 2335-1232S | Diameter: 12.0 Millimeter | In distribution |
| 2335-1146S | Length 460.0 mm | In distribution |
| 2360-5115S | Diameter: 5.0 Millimeter | In distribution |
| 2360-5030S | Length 30.0 mm | In distribution |
| 2337-1036S | Diameter: 10.0 Millimeter | In distribution |
| 2335-0930S | Diameter: 9.0 Millimeter | In distribution |
| 2335-1036S | Diameter: 10.0 Millimeter | In distribution |
| 2335-1344S | Length 440.0 mm | In distribution |
| 2337-0932S | Length 320.0 mm | In distribution |
| 2335-1332S | Length 320.0 mm | In distribution |
| 2360-5100S | Diameter: 5.0 Millimeter | In distribution |
| 2360-5052S | Length 52.5 mm | In distribution |
| 2337-0938S | Length 380.0 mm | In distribution |
| 2353-4114 | In distribution | |
| 2360-5025S | Length 25.0 mm | In distribution |
| 2353-4106 | In distribution | |
| 2335-1536S | Diameter: 15.0 Millimeter | In distribution |
| 2335-1542S | Diameter: 15.0 Millimeter | In distribution |
| 2335-1546S | Length 460.0 mm | In distribution |
| 2360-5027S | Diameter: 5.0 Millimeter | In distribution |
| 2335-1446S | Diameter: 14.0 Millimeter | In distribution |
| 2335-1034S | Diameter: 10.0 Millimeter | In distribution |
| 2360-5045S | Diameter: 5.0 Millimeter | In distribution |
| 2337-1146S | Diameter: 11.0 Millimeter | In distribution |
| 2337-0942S | Diameter: 9.0 Millimeter | In distribution |
| 2335-1228S | Diameter: 12.0 Millimeter | In distribution |
| 2335-1426S | Length 260.0 mm | In distribution |
| 2335-1226S | Length 260.0 mm | In distribution |
| 2335-1028S | Diameter: 10.0 Millimeter | In distribution |
| 2335-1026S | Diameter: 10.0 Millimeter | In distribution |
| 2353-3103 | In distribution | |
| 2335-0932S | Diameter: 9.0 Millimeter | In distribution |
| 2337-1126S | Length 260.0 mm | In distribution |
| 2353-3105 | In distribution | |
| 2335-1340S | Length 400.0 mm | In distribution |
| 2337-1538S | Length 380.0 mm | In distribution |
| 2337-1442S | Diameter: 14.0 Millimeter | In distribution |
| 2353-3104 | In distribution | |
| 2337-0934S | Length 340.0 mm | In distribution |
| 2335-1342S | Diameter: 13.0 Millimeter | In distribution |
| 2335-1140S | Diameter: 11.0 Millimeter | In distribution |
| 2337-1544S | Diameter: 15.0 Millimeter | In distribution |
| 2335-1134S | Diameter: 11.0 Millimeter | In distribution |
| 2353-3106 | In distribution | |
| 2360-5050S | Diameter: 5.0 Millimeter | In distribution |
| 2337-1534S | Length 340.0 mm | In distribution |
| 2337-0930S | Length 300.0 mm | In distribution |
| 2337-1332S | Diameter: 13.0 Millimeter | In distribution |
| 2337-0936S | Length 360.0 mm | In distribution |
| 2337-1138S | Length 380.0 mm | In distribution |
| 2335-1246S | Diameter: 12.0 Millimeter | In distribution |
| 2335-1138S | Length 380.0 mm | In distribution |
| 2335-1030S | Diameter: 10.0 Millimeter | In distribution |
| 2335-1428S | Diameter: 14.0 Millimeter | In distribution |
| 2335-0000S | Diameter: 8.0 Millimeter | In distribution |
| 2335-1528S | Diameter: 15.0 Millimeter | In distribution |
| 2335-1432S | Diameter: 14.0 Millimeter | In distribution |
| 2335-1348S | Length 480.0 mm | In distribution |
| 2335-0928S | Diameter: 9.0 Millimeter | In distribution |
| 2353-4109 | In distribution | |
| 2337-1244S | Length 440.0 mm | In distribution |
| 2337-0940S | Length 400.0 mm | In distribution |
| 2337-1530S | Length 300.0 mm | In distribution |
| 2337-1030S | Diameter: 10.0 Millimeter | In distribution |
| 2335-1024S | Length 240.0 mm | In distribution |
| 2360-5040S | Diameter: 5.0 Millimeter | In distribution |
| 2337-1128S | Length 280.0 mm | In distribution |
| 2335-0942S | Length 420.0 mm | In distribution |
| 2335-1330S | Length 300.0 mm | In distribution |
| 2360-5095S | Length 95.0 mm | In distribution |
| 2360-5080S | Diameter: 5.0 Millimeter | In distribution |
| 2337-0928S | Diameter: 9.0 Millimeter | In distribution |
| 2335-1128S | Length 280.0 mm | In distribution |
| 2360-5037S | Diameter: 5.0 Millimeter | In distribution |
| 2335-1142S | Length 420.0 mm | In distribution |
| 2335-1248S | Diameter: 12.0 Millimeter | In distribution |
| 2337-1540S | Length 400.0 mm | In distribution |
| 2360-5047S | Diameter: 5.0 Millimeter | In distribution |
| 2337-1048S | Diameter: 10.0 Millimeter | In distribution |
| 2360-5055S | Length 55.0 mm | In distribution |
| 2335-1444S | Length 440.0 mm | In distribution |
| 2335-1040S | Diameter: 10.0 Millimeter | In distribution |
| 2335-1334S | Length 340.0 mm | In distribution |
| 2360-5032S | Length 32.5 mm | In distribution |
| 2335-1240S | Diameter: 12.0 Millimeter | In distribution |
| 2335-1044S | Diameter: 10.0 Millimeter | In distribution |
| 2360-5075S | Length 75.0 mm | In distribution |
| 2335-0940S | Diameter: 9.0 Millimeter | In distribution |
| 2335-1336S | Diameter: 13.0 Millimeter | In distribution |
| 2337-1528S | Length 280.0 mm | In distribution |
| 2337-1130S | Diameter: 11.0 Millimeter | In distribution |
| 2335-1038S | Length 380.0 mm | In distribution |
| 2337-0946S | Diameter: 9.0 Millimeter | In distribution |
| 2337-1230S | Diameter: 12.0 Millimeter | In distribution |
| 2335-1436S | Diameter: 14.0 Millimeter | In distribution |
| 2337-1024S | Diameter: 10.0 Millimeter | In distribution |
| 2337-1136S | Diameter: 11.0 Millimeter | In distribution |
| 2335-1438S | Diameter: 14.0 Millimeter | In distribution |
| 2337-1546S | Length 460.0 mm | In distribution |
| 2360-5070S | Diameter: 5.0 Millimeter | In distribution |
| 2335-1328S | Diameter: 13.0 Millimeter | In distribution |
| 2335-1440S | Diameter: 14.0 Millimeter | In distribution |
| 2353-3911 | In distribution | |
| 2335-1524S | Length 240.0 mm | In distribution |
| 2335-1324S | Diameter: 13.0 Millimeter | In distribution |
| 2337-1428S | Diameter: 14.0 Millimeter | In distribution |
| 2337-1334S | Length 340.0 mm | In distribution |
| 2337-1542S | Length 420.0 mm | In distribution |
| 2335-1326S | Length 260.0 mm | In distribution |
| 2335-1124S | Length 240.0 mm | In distribution |
| 2337-1438S | Diameter: 14.0 Millimeter | In distribution |
| 2335-1238S | Length 380.0 mm | In distribution |
| 2337-1134S | Length 340.0 mm | In distribution |
| 2335-1224S | Length 240.0 mm | In distribution |
| 2335-1032S | Length 320.0 mm | In distribution |
| 2337-1038S | Diameter: 10.0 Millimeter | In distribution |
| 2335-1148S | Length 480.0 mm | In distribution |
| 2360-5057S | Diameter: 5.0 Millimeter | In distribution |
| 2337-1424S | Length 240.0 mm | In distribution |
| 2335-1346S | Diameter: 13.0 Millimeter | In distribution |
| 2337-1140S | Diameter: 11.0 Millimeter | In distribution |
| 2337-0926S | Diameter: 9.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220319 | 2022-06-10 |
| K213199 | 2022-01-11 |
| K193366 | 2020-03-20 |
| K183104 | 2019-06-10 |
| K180500 | 2018-06-04 |
| K173135 | 2017-11-27 |
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.