Link America, Inc.
Medical device manufacturer in Denville, NJ.
21510(k) clearances
0PMA approvals
0recalls
Device types
- HRS Plate, Fixation, Bone 3
- LZO Prosthesis, Hip, Semi-Constrained… 3
- JDL Prosthesis, Hip, Semi-Constrained (Metal… 2
- HWC Screw, Fixation, Bone 2
- JDR Staple, Fixation, Bone 2
- JDI Prosthesis, Hip, Semi-Constrained… 2
- KTT Appliance, Fixation, Nail/Blade/Plate… 2
- KWP Appliance, Fixation, Spinal Interlaminal 1
- KWS Prosthesis, Shoulder, Semi-Constrained… 1
- HTD Forceps 1
- HSX Prosthesis, Knee, Femorotibial… 1
- JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K972760 | Link, Acetabular Revision Mesh CupJDJ · Traditional | 10/22/1997SE |
| K964458 | Ellis External Mini-Fixator SystemKTT · Traditional | 12/09/1996SE |
| K955296 | Link MP Reconstruction HipJDI · Traditional | 02/14/1996SE |
| K954186 | Sled Unicompartment Knee SystemHSX · Traditional | 01/26/1996SE |
| K931571 | Link Ceramic Heads 12/14 X 32MMLZO · Traditional | 04/19/1994SN |
| K931572 | Link Ceramic Heads 14/16 X 32MMLZO · Traditional | 03/28/1994SE |
| K920756 | Feldmuhle Ceramic HeadLZO · Traditional | 05/18/1992SE |
| K914804 | Radius Osteotomy PlatesHRS · Traditional | 04/29/1992SN |
| K914803 | Schwabe Radius PlatesHRS · Traditional | 04/28/1992SE |
| K895507 | Link Giebel Blade Plate SystemKTT · Traditional | 03/13/1990SE |
| K873507 | Link (R) American-Type Bone Staple SystemJDR · Traditional | 09/16/1987SE |
| K871535 | Smiljanic Bone Repositioning ForcepsHTD · Traditional | 05/14/1987SE |
| K854935 | Link Metal-Backed Acetabular CupsJDL · Traditional | 03/05/1986SE |
| K854465 | Link Contour Ribbed Hip Prostheses SystemJDI · Traditional | 02/10/1986SE |
| K854825 | Link Small Bone PlatesHRS · Traditional | 01/21/1986SE |
| K853704 | Link Dynamic StapleJDR · Traditional | 01/21/1986SE |
| K854827 | Link Cortical ScrewsHWC · Traditional | 12/27/1985SE |
| K854826 | Link Cancellous ScrewsHWC · Traditional | 12/27/1985SE |
| K852365 | Link Shoulder Prosthesis Endo-Model SystemKWS · Traditional | 12/16/1985SE |
| K852369 | Lidgrer-Lund Acetabular SocketsJDL · Traditional | 06/18/1985SE |
| K840423 | Harrington-Type Instru-ScoliosisKWP · Traditional | 03/23/1984SE |