Kmedic
Dispnr Steinm PIN 12.25" FOR 3/32" 2.4MM
12manufacturers in China registered for this device type
227catalogue numbers in this listing
1510(k) clearance
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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K030336 |
| Record published | 2015-10-16 |
| Record revised | 2025-01-16 (version 11) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 4 to 12.875 in; width 0.7 to 4.5 mm; lumen/inner diameter 6 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN015749 | Length 6 in | 6 | In distribution |
| IPN015838 | Length 9 in | 6 | In distribution |
| IPN015851 | Length 7 in | 6 | In distribution |
| IPN015759 | Length 4 in | 6 | In distribution |
| IPN015937 | Width 2.4 mm | 6 | In distribution |
| IPN015834 | Width 0.9 mm | 6 | In distribution |
| IPN015839 | Width 1.6 mm | 6 | In distribution |
| IPN015736 | Length 6.25 in | In distribution | |
| IPN015936 | Width 2 mm | 6 | In distribution |
| IPN015922 | Width 4 mm | 6 | In distribution |
| IPN015846 | Length 9 in | 6 | In distribution |
| IPN015910 | Length 9 in | 6 | In distribution |
| IPN015890 | Width 2.8 mm | 6 | In distribution |
| IPN015796 | Length 5 in | 6 | In distribution |
| IPN015784 | Width 0.9 mm | 6 | In distribution |
| IPN015820 | Length 4 in | 6 | In distribution |
| IPN927763 | Length 9 in | 6 | In distribution |
| IPN015754 | Width 1.6 mm | 6 | In distribution |
| IPN015788 | Length 7 in | 6 | In distribution |
| IPN015746 | Width 0.7 mm | 6 | In distribution |
| IPN015735 | .055″ (1.4MM) | In distribution | |
| IPN015824 | Length 9 in | 6 | In distribution |
| IPN015739 | Length 12.875 in | In distribution | |
| IPN015919 | Length 9 in | 6 | In distribution |
| IPN015901 | Width 4 mm | 6 | In distribution |
| IPN015753 | Width 1.1 mm | 6 | In distribution |
| IPN927760 | Length 9 in | 6 | In distribution |
| IPN015837 | Length 9 in | 6 | In distribution |
| IPN015906 | Width 3.2 mm | 6 | In distribution |
| IPN015908 | Width 4 mm | 6 | In distribution |
| IPN015917 | Width 2 mm | 6 | In distribution |
| IPN015809 | Length 5 in | 6 | In distribution |
| IPN015938 | Width 2.8 mm | 6 | In distribution |
| IPN015732 | .031″ (0.8MM) | In distribution | |
| IPN015845 | Width 1.1 mm | 6 | In distribution |
| IPN015861 | Width 2.8 mm | 6 | In distribution |
| IPN015752 | Width 0.9 mm | 6 | In distribution |
| IPN015807 | Length 5 in | 6 | In distribution |
| IPN015921 | Length 9 in | 6 | In distribution |
| IPN015817 | Width 0.7 mm | 6 | In distribution |
| IPN015844 | Width 0.9 mm | 6 | In distribution |
| IPN015843 | Width 1.6 mm | 6 | In distribution |
| IPN015930 | Width 4.5 mm | 6 | In distribution |
| IPN927762 | Width 0.9 mm | 6 | In distribution |
| IPN015840 | Width 0.9 mm | 6 | In distribution |
| IPN015881 | Length 9 in | 6 | In distribution |
| IPN015760 | Width 1.4 mm | 6 | In distribution |
| IPN015748 | Width 1.1 mm | 6 | In distribution |
| IPN015907 | Length 9 in | 6 | In distribution |
| IPN015769 | Width 1.1 mm | 6 | In distribution |
| IPN015774 | Length 12 in | 6 | In distribution |
| IPN015909 | Length 9 in | 6 | In distribution |
| IPN015923 | Width 4.5 mm | 6 | In distribution |
| IPN015902 | Length 12 in | 6 | In distribution |
| IPN015793 | Length 12 in | 6 | In distribution |
| IPN015792 | Width 1.6 mm | 6 | In distribution |
| IPN015767 | Width 0.7 mm | 6 | In distribution |
| IPN015818 | Length 4 in | 6 | In distribution |
| IPN927752 | Width 0.9 mm | 6 | In distribution |
| IPN015941 | Width 4 mm | 6 | In distribution |
| IPN015865 | Width 4.5 mm | 6 | In distribution |
| IPN015876 | Length 9 in | 6 | In distribution |
| IPN015776 | Length 12 in | 6 | In distribution |
| IPN015869 | Width 3.2 mm | 6 | In distribution |
| IPN927756 | Width 1.6 mm | 6 | In distribution |
| IPN015847 | Width 0.9 mm | 6 | In distribution |
| IPN927750 | Length 6 in | 6 | In distribution |
| IPN015920 | Length 9 in | 6 | In distribution |
| IPN015741 | Length 12.875 in | In distribution | |
| IPN015801 | Width 1.6 mm | 6 | In distribution |
| IPN015915 | Width 4 mm | 6 | In distribution |
| IPN015743 | Length 12.875 in | In distribution | |
| IPN927755 | Length 5 in | 6 | In distribution |
| IPN015755 | Length 6 in | 6 | In distribution |
| IPN015785 | Length 9 in | 6 | In distribution |
| IPN015940 | Width 3.5 mm | 6 | In distribution |
| IPN015932 | Length 9 in | 6 | In distribution |
| IPN015924 | Width 2 mm | 6 | In distribution |
| IPN015913 | Width 3.2 mm | 6 | In distribution |
| IPN015842 | Length 9 in | 6 | In distribution |
| IPN927753 | Width 1.4 mm | 6 | In distribution |
| IPN015764 | Length 5 in | 6 | In distribution |
| IPN015783 | Length 9 in | 6 | In distribution |
| IPN015781 | Length 4 in | 6 | In distribution |
| IPN015871 | Length 9 in | 6 | In distribution |
| IPN015893 | Width 2 mm | 6 | In distribution |
| IPN015751 | Width 0.7 mm | 6 | In distribution |
| IPN015870 | Width 3.5 mm | 6 | In distribution |
| IPN015780 | Length 4 in | 6 | In distribution |
| IPN015800 | Width 1.1 mm | 6 | In distribution |
| IPN015886 | Width 4 mm | 6 | In distribution |
| IPN015810 | Length 5 in | 6 | In distribution |
| IPN015863 | Width 3.5 mm | 6 | In distribution |
| IPN015798 | Width 1.4 mm | 6 | In distribution |
| IPN015929 | Length 9 in | 6 | In distribution |
| IPN015935 | Length 9 in | 6 | In distribution |
| IPN015734 | Length 6.25 in | In distribution | |
| IPN015912 | Width 2.8 mm | 6 | In distribution |
| IPN015763 | Width 0.9 mm | 6 | In distribution |
| IPN015853 | Length 9 in | 6 | In distribution |
| IPN015885 | Width 3.5 mm | 6 | In distribution |
| IPN015899 | Width 3.2 mm | 6 | In distribution |
| IPN015884 | Width 3.2 mm | 6 | In distribution |
| IPN015927 | Width 3.2 mm | 6 | In distribution |
| IPN015873 | Length 9 in | 6 | In distribution |
| IPN927757 | Length 9 in | 6 | In distribution |
| IPN015772 | Width 0.7 mm | 6 | In distribution |
| IPN015866 | Length 9 in | 6 | In distribution |
| IPN015882 | Length 9 in | 6 | In distribution |
| IPN015852 | Width 2 mm | 6 | In distribution |
| IPN015775 | Length 12 in | 6 | In distribution |
| IPN015879 | Length 9 in | 6 | In distribution |
| IPN015939 | Length 9 in | 6 | In distribution |
| IPN015903 | Width 2 mm | 6 | In distribution |
| IPN015750 | Width 1.6 mm | 6 | In distribution |
| IPN015797 | Length 9 in | 6 | In distribution |
| IPN015826 | Width 1.4 mm | 6 | In distribution |
| IPN015831 | Width 1.4 mm | 6 | In distribution |
| IPN927749 | Lumen/Inner Diameter 6 in | 6 | In distribution |
| IPN015745 | Length 12.875 in | In distribution | |
| IPN015887 | Length 9 in | 6 | In distribution |
| IPN015791 | Width 1.1 mm | 6 | In distribution |
| IPN015815 | Length 9 in | 6 | In distribution |
| IPN015836 | Length 6 in | 6 | In distribution |
| IPN015828 | Length 12 in | 6 | In distribution |
| IPN015877 | Width 3.5 mm | 6 | In distribution |
| IPN927759 | Length 9 in | 6 | In distribution |
| IPN015850 | Width 2.4 mm | 6 | In distribution |
| IPN015789 | Length 12 in | 6 | In distribution |
| IPN927765 | Length 9 in | 6 | In distribution |
| IPN927764 | Length 9 in | 6 | In distribution |
| IPN015931 | Length 9 in | 6 | In distribution |
| IPN015811 | Width 1.6 mm | 6 | In distribution |
| IPN015799 | Length 5 in | 6 | In distribution |
| IPN015900 | Width 3.5 mm | 6 | In distribution |
| IPN015841 | Width 1.1 mm | 6 | In distribution |
| IPN015848 | Length 9 in | 6 | In distribution |
| IPN015891 | Width 3.2 mm | 6 | In distribution |
| IPN015904 | Width 2.4 mm | 6 | In distribution |
| IPN015827 | Width 0.7 mm | 6 | In distribution |
| IPN015766 | Width 1.6 mm | 6 | In distribution |
| IPN015856 | Width 3.5 mm | 6 | In distribution |
| IPN015747 | Length 6 in | 6 | In distribution |
| IPN015925 | Length 9 in | 6 | In distribution |
| IPN015768 | Length 9 in | 6 | In distribution |
| IPN015795 | Length 5 in | 6 | In distribution |
| IPN015872 | Length 9 in | 6 | In distribution |
| IPN015829 | Width 1.1 mm | 6 | In distribution |
| IPN015918 | Width 2.4 mm | 6 | In distribution |
| IPN015794 | Width 0.7 mm | 6 | In distribution |
| IPN015883 | Length 9 in | 6 | In distribution |
| IPN015786 | Length 9 in | 6 | In distribution |
| IPN927767 | Width 2.0 mm | 6 | In distribution |
| IPN015803 | Length 4 in | 6 | In distribution |
| IPN015802 | Width 0.7 mm | 6 | In distribution |
| IPN015896 | Width 2.8 mm | 6 | In distribution |
| IPN015888 | Width 2 mm | 6 | In distribution |
| IPN015816 | Length 9 in | 6 | In distribution |
| IPN015825 | Width 1.6 mm | 6 | In distribution |
| IPN015806 | Width 1.6 mm | 6 | In distribution |
| IPN015895 | Width 2.4 mm | 6 | In distribution |
| IPN015773 | Length 12 in | 6 | In distribution |
| IPN015778 | Length 4 in | 6 | In distribution |
| IPN015744 | 5/64″ (2MM) | In distribution | |
| IPN015833 | Length 9 in | 6 | In distribution |
| IPN927770 | Length 9 in | 6 | In distribution |
| IPN015765 | Length 5 in | 6 | In distribution |
| IPN015942 | Length 9 in | 6 | In distribution |
| IPN015867 | Length 9 in | 6 | In distribution |
| IPN015812 | Width 0.7 mm | 6 | In distribution |
| IPN015758 | Length 4 in | 6 | In distribution |
| IPN015814 | Width 1.1 mm | 6 | In distribution |
| IPN015779 | Length 4 in | 6 | In distribution |
| IPN015894 | Width 4 mm | 6 | In distribution |
| IPN015813 | Length 9 in | 6 | In distribution |
| IPN015878 | Length 9 in | 6 | In distribution |
| IPN015905 | Width 2.8 mm | 6 | In distribution |
| IPN015859 | Width 2 mm | 6 | In distribution |
| IPN015926 | Width 2.8 mm | 6 | In distribution |
| IPN015808 | Width 0.9 mm | 6 | In distribution |
| IPN015790 | Length 12 in | 6 | In distribution |
| IPN015857 | Length 9 in | 6 | In distribution |
| IPN015770 | Length 9 in | 6 | In distribution |
| IPN015864 | Length 9 in | 6 | In distribution |
| IPN015928 | Width 3.5 mm | 6 | In distribution |
| IPN015821 | Length 4 in | 6 | In distribution |
| IPN015916 | Length 9 in | 6 | In distribution |
| IPN015860 | Width 2.4 mm | 6 | In distribution |
| IPN015733 | Length 6.25 in | In distribution | |
| IPN015911 | Width 2.4 mm | 6 | In distribution |
| IPN015892 | Width 3.5 mm | 6 | In distribution |
| IPN015832 | Length 9 in | 6 | In distribution |
| IPN015830 | Length 12 in | 6 | In distribution |
| IPN015777 | Length 4 in | 6 | In distribution |
| IPN015874 | Width 2.4 mm | 6 | In distribution |
| IPN927754 | Width 1.6 mm | 6 | In distribution |
| IPN015761 | Width 1.6 mm | 6 | In distribution |
| IPN015771 | Length 9 in | 6 | In distribution |
| IPN015868 | Length 9 in | 6 | In distribution |
| IPN015804 | Length 4 in | 6 | In distribution |
| IPN927766 | Width 3.5 mm | 6 | In distribution |
| IPN015897 | Width 4.5 mm | 6 | In distribution |
| IPN015742 | Length 12.875 in | In distribution | |
| IPN927751 | Length 4 in | 6 | In distribution |
| IPN015805 | Length 4 in | 6 | In distribution |
| IPN927769 | Length 9 in | 6 | In distribution |
| IPN015934 | Length 9 in | 6 | In distribution |
| IPN015822 | Length 9 in | 6 | In distribution |
| IPN927768 | Length 9 in | 6 | In distribution |
| IPN015787 | Length 9 in | 6 | In distribution |
| IPN015933 | Length 9 in | 6 | In distribution |
| IPN015855 | Width 3.2 mm | 6 | In distribution |
| IPN015819 | Length 4 in | 6 | In distribution |
| IPN015862 | Length 9 in | 6 | In distribution |
| IPN015914 | Width 3.5 mm | 6 | In distribution |
| IPN015889 | Width 2.4 mm | 6 | In distribution |
| IPN015757 | Width 0.7 mm | 6 | In distribution |
| IPN015858 | Width 4.5 mm | 6 | In distribution |
| IPN015875 | Width 2.8 mm | 6 | In distribution |
| IPN015854 | Width 2.8 mm | 6 | In distribution |
| IPN015762 | Width 0.7 mm | In distribution | |
| IPN927771 | Length 9 in | 6 | In distribution |
| IPN927758 | Length 9 in | 6 | In distribution |
| IPN927761 | Length 4 in | 6 | In distribution |
| IPN015823 | Width 0.9 mm | 6 | In distribution |
| IPN015898 | Width 2.4 mm | 6 | In distribution |
| IPN015835 | Width 1.1 mm | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rondo’ | Citieffe SRL | 265 |
| HNM Medical | HNM Stainless, LLC. | 232 |
| 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 |
| Steinmann Pins, K-Wire, smooth | Gebr. Brasseler Gmbh & Co. KG | 110 |
Showing 12 of 682. All products under Pin, Fixation, Smooth
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070561 | 2007-05-25 |
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.