Distal Elbow Plating System
FreeFix, Proximal Ulna Plate, 8 Slot, Right
22manufacturers in China registered for this device type
156catalogue 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) | K231623 |
| Record published | 2018-04-30 |
| Record revised | 2025-11-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Threaded Peg, Non-Locking, 2.7mm x 34mm, Ti | In distribution | |
| Proximal Ulna Plate, 151mm, Left | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 65mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 28mm Cannulated, CoCr | In distribution | |
| Handle, Universal QC, Ratcheting | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 40mm Cannulated, CoCr | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 32mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 18mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 70mm, Ti | In distribution | |
| Screw, Cortical Locking, 3.5mm x 24mm, Ti | In distribution | |
| Screw, Polyaxial Non Locking, 3.5mm x 10mm, Ti – OBSOLETE | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 14mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 45mm, Ti | In distribution | |
| Screw, Cortical Locking, 3.5mm x 34mm, Ti | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 40 ,Ti | In distribution | |
| Threaded Peg, Locking, 1.8mm x 6mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 38mm, Ti | In distribution | |
| AIMing Guides, 2.0mm | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 55mm, Ti | In distribution | |
| Thread-In Drill Guide, 2.7mm, Multi-Thread | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 20mm, Ti | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 28mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 55mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 8mm, Ti | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 12 ,Ti | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 42mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 32mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 45mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 38mm, Ti | In distribution | |
| Proximal Ulna Plate, 108mm, Right | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 22 ,Ti | In distribution | |
| Screw, Polyaxial Non Locking, 3.5mm x 12mm, Ti – OBSOLETE | In distribution | |
| Threaded Peg, Non-Locking, 2.7mm x 40mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 18mm, Ti | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 34 ,Ti | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 20 ,Ti | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 24mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 10mm, Ti | In distribution | |
| Threaded Peg, Non-Locking, 2.7mm x 36mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 60mm, Ti | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 32 ,Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 60mm, Ti | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 17mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 24mm Cannulated, CoCr | In distribution | |
| Screw, Cortical Locking, 3.5mm x 30mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 50mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 12mm, Ti | In distribution | |
| Screw, Cortical Locking, 3.5mm x 38mm, Ti | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 26mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 38mm Cannulated, CoCr | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 24mm, Ti | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 30mm, Ti | In distribution | |
| PLS AIMing Guide, 1.1mm x 10° | In distribution | |
| Threaded Peg, Locking, 2.3mm x 36mm, Ti | In distribution | |
| Distal Elbow Set Tray B | In distribution | |
| Threaded Peg, Non-Locking, 2.7mm x 8mm, Ti | In distribution | |
| FreeFix, Proximal Ulna Plate, 8 Slot, Right | In distribution | |
| Threaded Peg, Non-Locking, 2.7mm x 38mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 22mm Cannulated, CoCr | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 70mm, Ti | In distribution | |
| Threaded Peg, Locking, 2.3mm x 8mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 34mm Cannulated, CoCr | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 20mm Cannulated, CoCr | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 32mm, Ti | In distribution | |
| Screw, Cortical Locking, 3.5mm x 17mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 20mm, Ti | In distribution | |
| Tissue Protector/Drill Guide, Dual Sided, 2.7mm x 2.7mm XL | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 36mm, Ti | In distribution | |
| Screw, Cortical Locking, 3.5mm x 44mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 14mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 26mm, Ti | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 16 ,Ti | In distribution | |
| Threaded Peg, Non-Locking, 2.7mm x 9mm, Ti | In distribution | |
| Distal Elbow Set Tray A | In distribution | |
| Proximal Ulna Plate, 108mm, Left | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 30mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 10mm, Ti | In distribution | |
| Depth Gauge, Universal, 50mm | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 50mm, Ti | In distribution | |
| Screw, Cortical Locking, 3.5mm x 22mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 16mm, Ti | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 22mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 8mm, Ti | In distribution | |
| Drill, 3.5mm x 70mm | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 12mm, Ti | In distribution | |
| Screw, Cortical Locking, 3.5mm x 40mm, Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 26mm Cannulated, CoCr | In distribution | |
| Screw, Cortical Locking, 3.5mm x 36mm, Ti | In distribution | |
| Threaded Peg, Locking, 2.3mm x 34mm, Ti | In distribution | |
| Threaded Peg, Locking, 2.3mm x 38mm, Ti | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 40mm, Ti | In distribution | |
| Large Reduction Forceps | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 65mm, Ti | In distribution | |
| Threaded Peg, Locking, 2.3mm x 40mm, Ti | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 38mm, Ti | In distribution | |
| Drill, 2.7mm x 40mm | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 16mm, Ti | In distribution | |
| DES | In distribution | |
| Screw, Cortical Locking, 3.5mm x 42mm, Ti | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 18 ,Ti | In distribution | |
| Countersink, 5.6mm | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 26mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 24mm, Ti | In distribution | |
| Radial Head Plate, Right | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 30mm, Ti | In distribution | |
| Proximal Ulna Plate, 151mm, Right | In distribution | |
| Cannulated Depth Gauge, Polyaxial Locking Screw, 3.0mm | In distribution | |
| Drill, 2.7mm x 80mm | In distribution | |
| Thread-In Drill Guide, 2.7mm, Multi-Thread, XL | In distribution | |
| Threaded Peg, Locking, 2.3mm x 7mm, Ti | In distribution | |
| K-Wire, Standard Tip, 1.1 mm x 152 mm | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 34mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 28mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 20mm, Ti | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 14 ,Ti | In distribution | |
| Screw, Cortical Locking, 3.5mm x 26mm, Ti | In distribution | |
| Bending Irons, PUP | In distribution | |
| Screw, Cortical Locking, 3.5mm x 28mm, Ti | In distribution | |
| Screw, Polyaxial Non Locking, 3.5mm x 14mm, Ti – OBSOLETE | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 28 ,Ti | In distribution | |
| Threaded Peg, Locking, 2.3mm x 9mm, Ti | In distribution | |
| Proximal Ulna Plate, 73mm, Right | In distribution | |
| Depth Gauge, Universal, 80mm | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 44mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 40mm, Ti | In distribution | |
| Distal Elbow System, Tray B – OBSOLETE | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 38 ,Ti | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 36 ,Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 22mm, Ti | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 34mm, Ti | In distribution | |
| K-Wire, Standard Tip, 1.5mm x 127mm | In distribution | |
| Screw, Cortical Non Locking, 3.5mm x 36mm, Ti | In distribution | |
| Screw, Cortical Locking, 3.5mm x 32mm, Ti | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 36mm, Ti | In distribution | |
| Radial Head Plate, Left | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 30mm Cannulated, CoCr | In distribution | |
| Threaded Peg, Non-Locking, 2.7mm x 7mm, Ti | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 10 ,Ti | In distribution | |
| Driver, 3.0 PLS, T-10 | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 30 ,Ti | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 36mm Cannulated, CoCr | In distribution | |
| Screw, Cortical Locking, 3.5mm x 20mm, Ti | In distribution | |
| Distal Elbow System, Tray A – OBSOLETE | In distribution | |
| Proximal Ulna Plate, 73mm, Left | In distribution | |
| Screw, Polyaxial Locking, 3.0mm x 32mm Cannulated, CoCr | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 28mm, Ti | In distribution | |
| Washer, Bronze | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 26 ,Ti | In distribution | |
| Screw, Polyaxial Non Locking, 3.5mm x 8mm, Ti – OBSOLETE | In distribution | |
| K-Wire, Standard Tip, 2.0 mm x 152 mm | In distribution | |
| Screw, Multi-Thread Compression, 3.5mm x 22mm, Ti | In distribution | |
| Threaded Peg, Non-Locking, 2.7mm x 6mm, Ti | In distribution | |
| Threaded Peg, Cortical Non-Locking, 2.7 x 24 ,Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 40mm, Ti | In distribution | |
| Threaded Peg, Locking, 2.3mm x 6mm, Ti | In distribution | |
| Screw, Multi-Thread Locking, 3.5mm x 34mm, Ti | 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.