Small Bone Phantom Intramedullary Nail System
Lapidus Nail, Outrigger Slider, 58mm/60mm, Right
1manufacturer
62catalogue numbers in this listing
1510(k) clearance
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 | Paragon 28, 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 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K182307 |
| Record published | 2019-10-17 |
| Record revised | 2025-04-22 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P30-R1-5544 | In distribution | |
| P30-L1-5546 | In distribution | |
| P30-R1-5538 | In distribution | |
| P30-L1-5544 | In distribution | |
| P30-L2-5538 | In distribution | |
| P30-R2-5544 | In distribution | |
| P30-R2-5550 | In distribution | |
| P30-L2-5556 | In distribution | |
| P30-R2-5538 | In distribution | |
| P30-R2-5558 | In distribution | |
| P30-L2-5540 | In distribution | |
| P30-R1-5554 | In distribution | |
| P30-R2-5546 | In distribution | |
| P30-L1-5556 | In distribution | |
| P30-L1-5554 | In distribution | |
| P30-R1-5548 | In distribution | |
| P30-R1-5552 | In distribution | |
| P30-900-027L | In distribution | |
| P30-L1-5560 | In distribution | |
| P30-900-100R | In distribution | |
| P30-L2-5554 | In distribution | |
| P30-R1-5540 | In distribution | |
| P30-R2-5552 | In distribution | |
| P30-L2-5546 | In distribution | |
| P30-R2-5560 | In distribution | |
| P30-900-047L | In distribution | |
| P30-900-031L | In distribution | |
| P30-900-047R | In distribution | |
| P30-900-100L | In distribution | |
| P30-R2-5542 | In distribution | |
| P30-L1-5538 | In distribution | |
| P30-R1-5556 | In distribution | |
| P30-R1-5550 | In distribution | |
| P30-L2-5558 | In distribution | |
| P30-900-043R | In distribution | |
| P30-L1-5548 | In distribution | |
| P30-L2-5560 | In distribution | |
| P30-R2-5556 | In distribution | |
| P30-L2-5542 | In distribution | |
| P30-L1-5558 | In distribution | |
| P30-L2-5548 | In distribution | |
| P30-R1-5546 | In distribution | |
| P30-900-035L | In distribution | |
| P30-R1-5542 | In distribution | |
| P30-R2-5548 | In distribution | |
| P30-L1-5540 | In distribution | |
| P30-900-035R | In distribution | |
| P30-900-040R | In distribution | |
| P30-900-040L | In distribution | |
| P30-L2-5550 | In distribution | |
| P30-L2-5552 | In distribution | |
| P30-R2-5540 | In distribution | |
| P30-L2-5544 | In distribution | |
| P30-L1-5552 | In distribution | |
| P30-R1-5558 | In distribution | |
| P30-900-031R | In distribution | |
| P30-R1-5560 | In distribution | |
| P30-R2-5554 | In distribution | |
| P30-900-043L | In distribution | |
| P30-900-027R | In distribution | |
| P30-L1-5542 | In distribution | |
| P30-L1-5550 | 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 |
| 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 |
| 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 |
|---|---|
| K170693 | 2017-06-19 |
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.