Humeral Plating System
109 catalogue numbers from Distal Humerus Plate, Lateral Helical, 8, listed by Skeletal Dynamics L.L.C., under Plate, Fixation, Bone. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
109catalogue numbers in this listing
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 | Skeletal Dynamics L.L.C. |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K200367 |
| Record published | 2020-11-25 |
| Record revised | 2025-11-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 2.1 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Distal Humerus Plate, Lateral Helical, 85mm, Right | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 10mm, Ti | In distribution | |
| Universal Bending Irons, 4.5mm | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 60mm, Ti | In distribution | |
| Trochlear Compression Screw, Male, 75mm | In distribution | |
| Hohmann Retractor, Large | In distribution | |
| Distal Humerus Plate, Lateral Helical, 115mm, Right | In distribution | |
| Distal Trochlea Compression Screw, 3.5mm x 80mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 14mm, Ti | In distribution | |
| Distal Humerus Plate, Lateral Capitellur, 100mm, Right | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 16mm, Ti | In distribution | |
| Distal Humerus Plate, Lateral Capitellur, 160mm, Left | In distribution | |
| Drill, 2.0mm x 80mm | Outer Diameter 2.1 mm | In distribution |
| Distal Humerus Plate, Medial Direct, 105mm, Left | In distribution | |
| Distal Humerus Plate, Supracondylar, 142mm, Left | In distribution | |
| Distal Humerus Plate, Supracondylar, 142mm, Right | In distribution | |
| Trochlear Compression Screw, Male, 80mm | In distribution | |
| Thread-In Drill Guide, FreeFix, 4.5mm | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 12mm, Ti | In distribution | |
| Distal Humerus Plate, Medial Direct, 105mm, Right | In distribution | |
| Midshaft Humerus Plate, Narrow 208mm | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 50mm, Ti | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 36mm, Ti | In distribution | |
| Driver, Universal, T15 | In distribution | |
| Distal Trochlea Compression Screw, 3.5mm x 55mm, Ti | In distribution | |
| Countersink, 6.5mm | In distribution | |
| Midshaft Humerus Plate, Broad 244mm | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 42mm Cannulated, CoCr | In distribution | |
| Distal Humerus Plate, Medial Direct, 75mm, Left | In distribution | |
| Distal Humerus Plate, Lateral Capitellur, 70mm, Right | In distribution | |
| Distal Humerus Plate, Lateral Direct, 115mm, Left | In distribution | |
| Distal Trochlea Compression Screw, 3.5mm x 75mm, Ti | In distribution | |
| Midshaft Humerus Plate, Narrow 172mm | In distribution | |
| Humeral Plating Set Tray A | In distribution | |
| Distal Humerus Plate, Medial Direct, 165mm, Right | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 60mm Cannulated, CoCr | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 38mm, Ti | In distribution | |
| Drill, Cannulated, 3.7mm x 80mm | In distribution | |
| Midshaft Humerus Plate, Narrow 136mm | In distribution | |
| Distal Humerus Plate, Supracondylar, 250mm, Right | In distribution | |
| Distal Humerus Plate, Lateral Helical, 85mm, Left | In distribution | |
| Distal Trochlea Compression Screw, 3.5mm x 70mm, Ti | In distribution | |
| Olecranon Osteotomy Guide | In distribution | |
| Distal Humerus Plate, Lateral Capitellur, 160mm, Right | In distribution | |
| Distal Trochlea Compression Screw, 3.5mm x 40mm, Ti | In distribution | |
| Distal Humerus Plate, Supracondylar, 196mm, Left | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 26mm, Ti | In distribution | |
| K-Wire, Single Trocar, 1.5 mm x 229 mm | In distribution | |
| Drill Guide, FreeFix™, HPS | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 44mm Cannulated, CoCr | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 26mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 32mm, Ti | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 70mm, Ti | In distribution | |
| Trochlear Compression Screw, Male, 50mm | In distribution | |
| Distal Trochlea Compression Screw, 3.5mm x 65mm, Ti | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 24mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 24mm, Ti | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 20mm, Ti | In distribution | |
| Trochlear Compression Screw, Male, 40mm | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 18mm, Ti | In distribution | |
| Distal Humerus Plate, Medial Direct, 75mm, Right | In distribution | |
| Distal Humerus Plate, Medial Direct, 165mm, Left | In distribution | |
| Distal Humerus Plate, Lateral Helical, 175mm, Right | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 54mm Cannulated, CoCr | In distribution | |
| Distal Humerus Plate, Lateral Direct, 175mm, Right | In distribution | |
| Distal Humerus Plate, Lateral Capitellur, 70mm, Left | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 60mm, Ti | In distribution | |
| Trochlear Compression Screw, Male, 70mm | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 30mm, Ti | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 28mm, Ti | In distribution | |
| Trochlear Compression Screw, Male, 55mm | In distribution | |
| Distal Humerus Plate, Medial Direct, 135mm, Right | In distribution | |
| Distal Humerus Plate, Lateral Direct, 145mm, Left | In distribution | |
| Distal Humerus Plate, Lateral Helical, 145mm, Left | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 18mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 58mm Cannulated, CoCr | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 38mm, Ti | In distribution | |
| Trochlear Compression Screw, Locking Cap | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 48mm Cannulated, CoCr | In distribution | |
| Distal Humerus Plate, Lateral Helical, 115mm, Left | In distribution | |
| Midshaft Humerus Plate, Broad 172mm | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 45mm, Ti | In distribution | |
| Trochlear Compression Screw, Male, 65mm | In distribution | |
| Distal Humerus Plate, Lateral Helical, 175mm, Left | In distribution | |
| Bending Rod, DHP | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 16mm, Ti | In distribution | |
| Cannulated Depth Gauge, Polyaxial Locking Screw, 3.0mm x 60mm | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 28mm, Ti | In distribution | |
| Distal Humerus Plate, Lateral Capitellur, 100mm, Left | In distribution | |
| Distal Humerus Plate, Lateral Helical, 145mm, Right | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 14mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 52mm Cannulated, CoCr | In distribution | |
| Distal Humerus Plate, Lateral Capitellur, 130mm, Right | In distribution | |
| Distal Humerus Plate, Supracondylar, 250mm, Left | In distribution | |
| Distal Trochlea Compression Screw, 3.5mm x 50mm, Ti | In distribution | |
| Distal Humerus Plate, Medial Direct, 135mm, Left | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 32mm, Ti | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 45mm, Ti | In distribution | |
| Trochlear Compression Screw, Female | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 40mm, Ti | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 65mm, Ti | In distribution | |
| Distal Humerus Plate, Supracondylar, 196mm, Right | In distribution | |
| Screw, Multi-Thread, Compression, 2.7mm x 22mm, Ti | In distribution | |
| Trochlear Compression Screw, Male, 45mm | In distribution | |
| Screw, Multi-Thread, Locking, 2.7mm x 10mm, Ti | In distribution | |
| Distal Humerus Plate, Lateral Direct, 175mm, Left | In distribution | |
| Drill, 3.2mm / 4.5mm | In distribution | |
| Trajectory Guide | In distribution | |
| Midshaft Humerus Plate, Narrow 244mm | In distribution |
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
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.