Contours Proximal Humeral Plate (Php) & Lsp Titanium Humeral Plate
Titanium Hexagonal Threaded Wires D.2,2 MM 120/20 MM (Pack OF 2)
1manufacturer
49catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Orthofix SRL, Italy |
|---|---|
| FDA product code | KTW |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K062920 |
| Record published | 2016-09-16 |
| Record revised | 2025-10-24 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Length 22 to 200 mm; width 144 to 151 mm; outer diameter 2 to 4.8 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Length 30 mm | In distribution |
| 1 | Outer Diameter 2 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Width 144 mm | In distribution |
| 1 | Length 28 mm | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Length 28 mm | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | Outer Diameter 3.2 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Length 24 mm | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Width 149 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 148 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 200 mm | In distribution |
| 1 | Length 150 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 36 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Length 26 mm | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | Length 22 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | Width 145 mm | In distribution |
| 1 | Length 150 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 4.8 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Width 146 mm | In distribution |
| 1 | Length 26 mm | In distribution |
| 1 | Width 150 mm | In distribution |
| 1 | Length 34 mm | In distribution |
| 1 | Length 34 mm | In distribution |
| 1 | Width 151 mm | In distribution |
| 1 | Width 147 mm | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | THREAD DIAMETER 2.2 MM | In distribution |
| 1 | Length 120 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | Synthes Gmbh | 332 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | Synthes (U.S.A.) LP | 118 |
| Matta | Stryker GmbH | 72 |
| Small Bone Phantom Intramedullary Nail System | Paragon 28 | 62 |
| Contours Proximal Humeral Plate (PHP) | Orthofix SRL | 29 |
| Cancellous Locking Screw, Fully Threaded 4.0mm x 54mm | Advanced Orthopaedic Solutions, Inc. | 23 |
| AOS Cancellous Locking Screw, Partial Thread 4.0mm x 38mm | Advanced Orthopaedic Solutions, Inc. | 23 |
| AOS Cancellous Locking Screw, Fully Threaded 4.0mm x 26mm | Advanced Orthopaedic Solutions, Inc. | 23 |
| LSP Titanium Humeral Plate | Orthofix SRL | 12 |
| LCP | Synthes Gmbh | 8 |
| LCP | Synthes (U.S.A.) LP | 4 |
| VHS Vari-Angle HIP System | Biomet Orthopedics | 2 |
Showing 12 of 74. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122541 | 2012-09-20 |
| K062920 | 2006-11-13 |
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.