Assembly, Thigh/Knee/Shank/Ankle/Foot, External
FDA product code KFX · Class II (moderate risk) · 21 CFR 890.3500 · Physical Medicine
4510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932184 | Sterile Lemaitre Glow 'N Tell TapeKFX · Traditional | Vascutech, Inc. | 07/22/1993SE |
| K833868 | Ipos G.L.P. SystemKFX · Traditional | Ipos Luneburg | 11/28/1983SE |
| K830285 | Regnell Hydraulic Femoral ProthesisKFX · Traditional | Besco Financial Service | 03/09/1983SE |
| K822240 | Ethylene Oxide Steriliz. Parametric Rel.KFX · Traditional | American Mcgaw | 12/30/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1055-2013 Class II | Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips).…Devices were not sealed correctly during the manufacturing process, and the sterility of these products have… | LeMaitre Vascular, Inc. | 03/18/2013Terminated |
| Z-1054-2013 Class II | LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips).…Devices were not sealed correctly during the manufacturing process, and the sterility of these products have… | LeMaitre Vascular, Inc. | 03/18/2013Terminated |
| Z-0363-2007 | Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively…A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being… | Bock,Otto,Orthopedic Ind,Inc | 08/10/2006Terminated |