LSP Titanium Humeral Plate
K-Wires (D. 2MM) L. 200MM (Pack OF 4) Sterile
1manufacturer
12catalogue 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 | 2015-09-01 |
| Record revised | 2025-11-20 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 2 to 3.2 mm; length 20 to 200 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Length 50 mm | In distribution |
| 1 | Length 20 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 45 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Outer Diameter 3.2 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 200 mm | In distribution |
| 1 | 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) & Lsp Titanium Humeral Plate | Orthofix SRL | 49 |
| 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 |
| 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.