Cortical Locking Screw 3.5mm X 36mm
Catalogue number 8012-360, listed by Advanced Orthopaedic Solutions, Inc., United States, under Appliance, Fixation, Nail/Blade/Plate Combination, Single Component. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
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 | Advanced Orthopaedic Solutions, Inc., United States |
|---|---|
| FDA product code | KTW |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Record published | 2015-12-22 |
| Record revised | 2025-12-30 (version 6) |
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, expiry date |
| Distribution end date | 2025-12-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8012-360 | Withdrawn |
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 |
| LSP Titanium Humeral Plate | Orthofix SRL | 12 |
| LCP | Synthes Gmbh | 8 |
| LCP | Synthes (U.S.A.) LP | 4 |
Showing 12 of 74. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160409 | 2016-03-15 |
| K080590 | 2008-05-06 |
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.