TriLeap Lower Extremity Anatomic Plating System
3.5 mm Ti Variable Angle Screw Length 52 mm, Dark Purple
22manufacturers in China registered for this device type
424catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Crossroads Extremity Systems LLC, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K253178 |
| Record published | 2026-02-18 |
| Record revised | 2026-05-14 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.900.090 | In distribution | |
| 2.0 T-Shape Ti Fracture Plate, 4 Hole | In distribution | |
| 04.900.100 | In distribution | |
| 3.0 mm Ti Cortex Screw Length 54 mm, Rose Red | In distribution | |
| 1st MTP Ti Fusion Plate, Medium, 5 Deg, Right | In distribution | |
| 2.0 mm Ti Cortex Screw Length 10 mm, Blue | In distribution | |
| 2.0 mm Ti Cortex Screw Length 30 mm, Blue | In distribution | |
| 04.900.157 | In distribution | |
| 04.900.225 | In distribution | |
| 3.0 mm Ti Cortex Screw Length 46 mm, Rose Red | In distribution | |
| 4.0 mm Ti Cortex Screw Length 16 mm, Green | In distribution | |
| 2.5 mm Ti Cortex Screw Length 18 mm, Magenta | In distribution | |
| 3.0 mm Ti Cortex Screw Length 32 mm, Gold | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 26 mm, Rose Red | In distribution | |
| 3.0 mm Ti Cortex Screw Length 34 mm, Rose Red | In distribution | |
| 04.900.160 | In distribution | |
| 4.0 mm Ti Cortex Screw Length 56 mm, Green | In distribution | |
| 2.0 Y-Shape Ti Fracture Plate, 3 Hole | In distribution | |
| 04.900.156 | In distribution | |
| 2.5 mm Ti Variable Angle Screw Length 20 mm, Magenta | In distribution | |
| 04.900.133 | In distribution | |
| 1st MTP Ti Fusion Revision Plate, Medium, 0 Deg, Left | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 24 mm, Gold | In distribution | |
| 2.0 mm Ti Variable Angle Screw Length 8 mm, Blue | In distribution | |
| 04.900.148 | In distribution | |
| 3.5 mm Ti Cortex Screw Length 54 mm, Dark Purple | In distribution | |
| 04.900.085 | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 36 mm, Gold | In distribution | |
| 04.900.150 | In distribution | |
| 3.0 mm Ti Cortex Screw Length 42 mm, Rose Red | In distribution | |
| 3.5 mm Ti Cortex Screw Length 42 mm, Dark Purple | In distribution | |
| 2.5 mm Ti Cortex Screw Length 30 mm, Magenta | In distribution | |
| 04.900.228 | In distribution | |
| 3.0 mm Ti Cortex Screw Length 28 mm, Rose Red | In distribution | |
| General Instruments Module | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 52 mm, Dark Purple | In distribution | |
| 4.0 mm Ti Cortex Screw Length 38 mm, Green | In distribution | |
| 04.900.229 | In distribution | |
| 04.900.087 | In distribution | |
| 04.900.120 | In distribution | |
| 2.0 mm Ti Variable Angle Screw Length 16 mm, Blue | In distribution | |
| 4.0 mm Ti Cortex Screw Length 50 mm, Green | In distribution | |
| 2.0 Straight Ti Fracture Plate, 3 Hole | In distribution | |
| 3.0 mm Ti Cortex Screw Length 38 mm, Gold | In distribution | |
| 4.0 mm Ti Variable Angle Screw Length 50 mm, Green | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 18 mm, Rose Red | In distribution | |
| Lapidus Ti Plate 2 mm Step, Right | In distribution | |
| 4.0 mm Ti Cortex Screw Length 54 mm, Green | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 32 mm, Gold | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 18 mm, Gold | In distribution | |
| 3.5 mm Ti Cortex Screw Length 60 mm, Dark Purple | In distribution | |
| Implant Module for Midfoot Fracture Plates | In distribution | |
| 2.5 mm Ti Variable Angle Screw Length 24 mm, Magenta | In distribution | |
| 3.5 mm Ti Cortex Screw Length 18 mm, Dark Purple | In distribution | |
| 2.5 mm Ti Cortex Screw Length 8 mm, Magenta | In distribution | |
| 04.900.099 | In distribution | |
| 4.0 mm Ti Cortex Screw Length 18 mm, Green | In distribution | |
| 04.900.119 | In distribution | |
| 04.900.125 | In distribution | |
| 04.900.136 | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 42 mm, Rose Red | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 20 mm, Gold | In distribution | |
| 3.5 mm Ti Cortex Screw Length 36 mm, Dark Purple | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 44 mm, Rose Red | In distribution | |
| 04.900.226 | In distribution | |
| Lapidus Ti Plate 2 mm Step, Left | In distribution | |
| 04.900.145 | In distribution | |
| 4.0 mm Ti Cortex Screw Length 24 mm, Green | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 14 mm, Rose Red | In distribution | |
| 1st MTP Ti Fusion Plate, Small, 10 Deg, Right | In distribution | |
| 3.0 mm Ti Cortex Screw Length 50 mm, Rose Red | In distribution | |
| 04.900.088 | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 24 mm, Rose Red | In distribution | |
| 04.900.146 | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 50 mm, Rose Red | In distribution | |
| 04.900.106 | In distribution | |
| 04.900.101 | In distribution | |
| 04.900.097 | In distribution | |
| NC Ti Fusion 5 hole, Long, Right | In distribution | |
| 3.0 mm Ti Cortex Screw Length 18 mm, Gold | In distribution | |
| 2.0 mm Ti Cortex Screw Length 28 mm, Blue | In distribution | |
| 2.0 mm Ti Variable Angle Screw Length 13 mm, Blue | In distribution | |
| 3.0 mm Ti Cortex Screw Length 24 mm, Rose Red | In distribution | |
| 2.5 mm Ti Cortex Screw Length 9 mm, Magenta | In distribution | |
| 3.0 mm Ti Cortex Screw Length 36 mm, Rose Red | In distribution | |
| 2.5 mm Ti Cortex Screw Length 24 mm, Magenta | In distribution | |
| 1st MTP Ti Fusion Plate, Medium, 5 Deg, Left | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 40 mm, Rose Red | In distribution | |
| 4.0 mm Ti Variable Angle Screw Length 14 mm, Green | In distribution | |
| 2.0 T-Shape Ti Fracture Plate, 5 Hole | In distribution | |
| Medial Ti Talar Neck Plate, Right | In distribution | |
| 04.900.091 | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 30 mm, Gold | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 20 mm, Dark Purple | In distribution | |
| 2.0 Straight Ti Fracture Plate, 6 Hole | In distribution | |
| 4.0 mm Ti Variable Angle Screw Length 32 mm, Green | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 58 mm, Dark Purple | In distribution | |
| 04.900.158 | In distribution | |
| 04.900.159 | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 22 mm, Gold | In distribution | |
| 3.5 mm Ti Cortex Screw Length 10 mm, Dark Purple | In distribution | |
| 2.0 mm Ti Variable Angle Screw Length 14 mm, Blue | In distribution | |
| 04.900.113 | In distribution | |
| 1st & 2nd Ti Lisfranc Joint Fusion Plate, Large, Right | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 40 mm, Gold | In distribution | |
| 04.900.144 | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 16 mm, Dark Purple | In distribution | |
| 04.900.108 | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 38 mm, Gold | In distribution | |
| Lapidus Ti Plate 4 mm Step, Left | In distribution | |
| 2.0 Y-Shape Ti Fracture Plate, 6 Hole | In distribution | |
| Lapidus Ti Plate 4 mm Step, Right | In distribution | |
| 04.900.154 | In distribution | |
| 04.900.223 | In distribution | |
| 04.900.086 | In distribution | |
| 2.5 mm Ti Cortex Screw Length 22 mm, Magenta | In distribution | |
| 04.900.224 | In distribution | |
| 2nd & 3rd Ti Lisfranc Joint Fusion Plate, Medium, Right | In distribution | |
| 3.5 mm Ti Cortex Screw Length 14 mm, Dark Purple | In distribution | |
| 2.0 mm Ti Variable Angle Screw Length 12 mm, Blue | In distribution | |
| 3.5 mm Ti Cortex Screw Length 32 mm, Dark Purple | In distribution | |
| 3.0 mm Ti Cortex Screw Length 22 mm, Rose Red | In distribution | |
| 2.5 mm Ti Variable Angle Screw Length 8 mm, Magenta | In distribution | |
| 3.0 mm Ti Cortex Screw Length 52 mm, Rose Red | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 16 mm, Rose Red | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 52 mm, Rose Red | In distribution | |
| 04.900.083 | In distribution | |
| NC Ti Fusion 5 hole, Short, Right | In distribution | |
| 04.900.135 | In distribution | |
| 2.5 mm Ti Variable Angle Screw Length 16 mm, Magenta | In distribution | |
| 1st & 2nd Ti Lisfranc Joint Fusion Plate, Medium, Right | In distribution | |
| 2.0 Straight Ti Fracture Plate, 7 Hole | In distribution | |
| Cuboid H Ti Plate, Left | In distribution | |
| 3.0 mm Ti Cortex Screw Length 12 mm, Gold | In distribution | |
| 2.0 T-Shape Ti Fracture Plate, 6 Hole | In distribution | |
| 3.0 mm Ti Cortex Screw Length 20 mm, Gold | In distribution | |
| 3.5 mm Ti Cortex Screw Length 20 mm, Dark Purple | In distribution | |
| 4.0 mm Ti Variable Angle Screw Length 46 mm, Green | In distribution | |
| 2.0 T-Shape Ti Fracture Plate, 3 Hole | In distribution | |
| 2nd & 3rd Ti Lisfranc Joint Fusion Plate, Large, Left | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 10 mm, Rose Red | In distribution | |
| 4.0 mm Ti Cortex Screw Length 36 mm, Green | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 14 mm, Dark Purple | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 54 mm, Dark Purple | In distribution | |
| 04.900.096 | In distribution | |
| 3.0 mm Ti Cortex Screw Length 12 mm, Rose Red | In distribution | |
| 04.900.153 | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 14 mm, Gold | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 20 mm, Rose Red | In distribution | |
| 2.5 mm Ti Variable Angle Screw Length 9 mm, Magenta | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 54 mm, Rose Red | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 18 mm, Dark Purple | In distribution | |
| 3.0 mm Ti Cortex Screw Length 10 mm, Rose Red | In distribution | |
| 4.0 mm Ti Cortex Screw Length 20 mm, Green | In distribution | |
| 2nd & 3rd Ti Lisfranc Joint Fusion Plate, Medium, Left | In distribution | |
| 2.5 mm Ti Cortex Screw Length 40 mm, Magenta | In distribution | |
| Cuboid W Ti Plate, Standard | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 46 mm, Rose Red | In distribution | |
| 2.5 mm Ti Variable Angle Screw Length 15 mm, Magenta | In distribution | |
| 4.0 mm Ti Cortex Screw Length 48 mm, Green | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 48 mm, Rose Red | In distribution | |
| 4.0 mm Ti Cortex Screw Length 30 mm, Green | In distribution | |
| Navicular Ti Plate, Long | In distribution | |
| 2.5 mm Ti Cortex Screw Length 36 mm, Magenta | In distribution | |
| 4.0 mm Ti Variable Angle Screw Length 18 mm, Green | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 15 mm, Gold | In distribution | |
| 3.5 mm Ti Cortex Screw Length 56 mm, Dark Purple | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 56 mm, Dark Purple | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 34 mm, Rose Red | In distribution | |
| 04.900.134 | In distribution | |
| 04.900.092 | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 28 mm, Rose Red | In distribution | |
| 2.5 mm Ti Cortex Screw Length 16 mm, Magenta | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 10 mm, Dark Purple | In distribution | |
| Lapidus Ti Plate 0 mm Step, Right | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 12 mm, Dark Purple | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 38 mm, Rose Red | In distribution | |
| 2.0 mm Ti Variable Angle Screw Length 26 mm, Blue | In distribution | |
| 04.900.132 | In distribution | |
| 1st & 2nd Ti Lisfranc Joint Fusion Plate, Medium, Left | In distribution | |
| 04.900.079 | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 30 mm, Rose Red | In distribution | |
| 3.0 mm Ti Cortex Screw Length 38 mm, Rose Red | In distribution | |
| 04.900.123 | In distribution | |
| 3.0 mm Ti Cortex Screw Length 36 mm, Gold | In distribution | |
| 04.900.114 | In distribution | |
| 04.900.221 | In distribution | |
| 04.900.151 | In distribution | |
| 2.0 mm Ti Variable Angle Screw Length 28 mm, Blue | In distribution | |
| 04.900.143 | In distribution | |
| 2.0 mm Ti Variable Angle Screw Length 24 mm, Blue | In distribution | |
| 2.0 mm Ti Cortex Screw Length 14 mm, Blue | In distribution | |
| 04.900.137 | In distribution | |
| 3.0 mm Ti Cortex Screw Length 58 mm, Rose Red | In distribution | |
| 3.0 mm Ti Cortex Screw Length 56 mm, Rose Red | In distribution | |
| 4.0 mm Ti Cortex Screw Length 32 mm, Green | In distribution | |
| 04.900.081 | In distribution | |
| 3.0 mm Ti Cortex Screw Length 18 mm, Rose Red | In distribution | |
| 2.5 mm Ti Variable Angle Screw Length 14 mm, Magenta | In distribution | |
| 3.5 mm Ti Cortex Screw Length 16 mm, Dark Purple | In distribution | |
| 4.0 mm Ti Variable Angle Screw Length 42 mm, Green | In distribution | |
| 3.0 mm Ti Cortex Screw Length 30 mm, Gold | In distribution | |
| 04.900.112 | In distribution | |
| 3.5 mm Ti Cortex Screw Length 46 mm, Dark Purple | In distribution | |
| 4.0 mm Ti Cortex Screw Length 60 mm, Green | In distribution | |
| 4.0 mm Ti Variable Angle Screw Length 52 mm, Green | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 46 mm, Dark Purple | In distribution | |
| 2.5 mm Ti Variable Angle Screw Length 34 mm, Magenta | In distribution | |
| 04.900.138 | In distribution | |
| 3.0 mm Ti Cortex Screw Length 32 mm, Rose Red | In distribution | |
| 2.0 Straight Ti Fracture Plate, 8 Hole | In distribution | |
| 1st MTP Ti Fusion Plate, Medium, 0 Deg, Left | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 26 mm, Gold | In distribution | |
| 2.0 mm Ti Variable Angle Screw Length 22 mm, Blue | In distribution | |
| 2.5 mm Ti Cortex Screw Length 20 mm, Magenta | In distribution | |
| 4.0 mm Ti Cortex Screw Length 12 mm, Green | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 24 mm, Dark Purple | In distribution | |
| 3.5 mm Ti Cortex Screw Length 22 mm, Dark Purple | In distribution | |
| 3.0 mm Ti Cortex Screw Length 10 mm, Gold | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 56 mm, Rose Red | In distribution | |
| 1st MTP Ti Fusion Plate, Medium, 10 Deg, Left | In distribution | |
| 2.5 mm Ti Cortex Screw Length 28 mm, Magenta | In distribution | |
| 3.0 mm Ti Cortex Screw Length 16 mm, Rose Red | In distribution | |
| Screw Rack for 2.0/2.5/3.0 Screws | In distribution | |
| 3.0 mm Ti Cortex Screw Length 40 mm, Gold | In distribution | |
| 60.900.313 | In distribution | |
| TN Ti Fusion Plate, Long | In distribution | |
| 2.5 mm Ti Cortex Screw Length 32 mm, Magenta | In distribution | |
| 04.900.142 | In distribution | |
| Instruments Module for 3.0/3.5/4.0 Foot Plating System | In distribution | |
| 4.0 mm Ti Cortex Screw Length 58 mm, Green | In distribution | |
| 2.5 mm Ti Variable Angle Screw Length 12 mm, Magenta | In distribution | |
| 04.900.147 | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 50 mm, Dark Purple | In distribution | |
| 2.5 mm Ti Variable Angle Screw Length 36 mm, Magenta | In distribution | |
| 4.0 mm Ti Variable Angle Screw Length 20 mm, Green | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 28 mm, Dark Purple | In distribution | |
| 3.5 mm Ti Variable Angle Screw Length 44 mm, Dark Purple | In distribution | |
| 1st & 2nd Ti Lisfranc Joint Fusion Plate, Small, Left | In distribution | |
| 4.0 mm Ti Variable Angle Screw Length 40 mm, Green | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 22 mm, Rose Red | In distribution | |
| 4.0 mm Ti Cortex Screw Length 14 mm, Green | In distribution | |
| 3.0 mm Ti Variable Angle Screw Length 8 mm, Gold | In distribution | |
| Medial Ti Talar Neck Plate, Left | In distribution | |
| 4.0 mm Ti Cortex Screw Length 22 mm, Green | In distribution | |
| 2.5 mm Ti Variable Angle Screw Length 40 mm, Magenta | In distribution | |
| 60.900.314 | In distribution | |
| 04.900.128 | In distribution | |
| 04.900.121 | In distribution | |
| 04.900.126 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253178 | 2026-01-06 |
| K230591 | 2023-09-29 |
| K223342 | 2023-03-30 |
| K190658 | 2019-04-12 |
| K181872 | 2019-02-19 |
| K160300 | 2016-04-22 |
| K152306 | 2015-12-11 |
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.