K-Wires Trocar Tip Round End
TiAl6V4 ELI non-sterile QTY 10
12manufacturers in China registered for this device type
53catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Merete Gmbh, Germany |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K120787 |
| Record published | 2015-10-15 |
| Record revised | 2024-02-19 (version 7) |
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 |
| Sizes | Length 70 to 310 mm; outer diameter 1 to 2 mm; outer diameter 1.6 µm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.00 225 | Length 225 mm | In distribution |
| 1.60 150 | Outer Diameter 1.6 mm | In distribution |
| 1.20 310 | Length 310 mm | In distribution |
| 1.80 80 | Length 80 mm | In distribution |
| 1.20 310 | Length 310 mm | In distribution |
| 2.00 280 | Length 280 mm | In distribution |
| 2.00 80 | Length 80 mm | In distribution |
| 1.60 150 | Length 150 mm | In distribution |
| 1.60 80 | Outer Diameter 1.6 mm | In distribution |
| 2.00 150 | Length 150 mm | In distribution |
| 1.20 115 | Length 115 mm | In distribution |
| 1.60 280 | Length 280 mm | In distribution |
| 1.00 150 | Length 150 mm | In distribution |
| 1.70 80 | Length 80 mm | In distribution |
| 1.60 310 | Length 310 mm | In distribution |
| 1.40 70 | Length 70 mm | In distribution |
| 1.20 180 | Length 180 mm | In distribution |
| 1.40 150 | Length 150 mm | In distribution |
| 2.00 250 | Length 250 mm | In distribution |
| 1.00 150 | Outer Diameter 1 mm | In distribution |
| 1.50 150 | Length 150 mm | In distribution |
| 1.60 80 | Length 80 mm | In distribution |
| 1.40 70 | Outer Diameter 1.4 mm | In distribution |
| 1.60 150 | Length 150 mm | In distribution |
| 1.80 310 | Length 310 mm | In distribution |
| 1.40 310 | Length 310 mm | In distribution |
| 1.00 150 | Length 150 mm | In distribution |
| 1.80 150 | Length 150 mm | In distribution |
| 1.40 150 | Length 150 mm | In distribution |
| 2.00 310 | Length 310 mm | In distribution |
| 1.10 80 | Length 80 mm | In distribution |
| 1.20 80 | Length 80 mm | In distribution |
| 1.20 200 | Length 200 mm | In distribution |
| 1.40 80 | Length 80 mm | In distribution |
| 1.00 310 | Length 310 mm | In distribution |
| 1.40 310 | Length 310 mm | In distribution |
| 1.40 150 | Outer Diameter 1.4 mm | In distribution |
| 2.00 150 | Length 150 mm | In distribution |
| 1.25 180 | Length 180 mm | In distribution |
| 1.00 70 | Length 70 mm | In distribution |
| 2.00 230 | Length 230 mm | In distribution |
| 1.00 100 | Outer Diameter 1 mm | In distribution |
| 1.30 80 | Length 80 mm | In distribution |
| 1.00 100 | Length 100 mm | In distribution |
| 1.80 150 | Length 150 mm | In distribution |
| 1.00 70 | Outer Diameter 1 mm | In distribution |
| 2.00 230 | Outer Diameter 2.0 mm | In distribution |
| 1.60 310 | Length 310 mm | In distribution |
| 1.50 80 | Length 80 mm | In distribution |
| 1.25 150 | Length 150 mm | In distribution |
| 1.80 310 | Length 310 mm | In distribution |
| 1.90 80 | Length 80 mm | In distribution |
| 1.00 80 | Length 80 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rondo’ | Citieffe SRL | 265 |
| HNM Medical | HNM Stainless, LLC. | 232 |
| Kmedic | Teleflex Medical LLC | 227 |
| gSource | Gsource, LLC. | 221 |
| MicroAire® | Microaire Surgical Instruments LLC | 213 |
| Orthomed | Ortho-MED, Inc. | 163 |
| mahe medical GmbH | Mahe Intl., Inc. | 160 |
| Pin, Fixation, Smooth | Key Surgical, LLC | 134 |
| Pin, Fixation, Smooth | Stryker GmbH | 134 |
| Aptus | Medartis Inc. | 134 |
| Key Surgical K-Wires and Steinmann Pins | Key Surgical, LLC | 126 |
| PedFlex Flexible Nailing System | Orthopediatrics, Corp | 119 |
Showing 12 of 682. All products under Pin, Fixation, Smooth
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.