Company ยท US
Link America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1997. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRS | Plate, Fixation, Bone | 3 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 |
| HWC | Screw, Fixation, Bone | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 2 |
| JDR | Staple, Fixation, Bone | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 |
| HTD | Forceps | 1 |
| JDJ | Mesh, Surgical, Acetabular, Hip, Prosthesis | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 1997 | K972760 | LINK, ACETABULAR REVISION MESH CUP Link America, Inc. | JDJ |
| Dec 9, 1996 | K964458 | ELLIS EXTERNAL MINI-FIXATOR SYSTEM Link America, Inc. | KTT |
| Feb 14, 1996 | K955296 | LINK MP RECONSTRUCTION HIP Link America, Inc. | JDI |
| Jan 26, 1996 | K954186 | SLED UNICOMPARTMENT KNEE SYSTEM Link America, Inc. | HSX |
| Apr 19, 1994 | K931571 | LINK CERAMIC HEADS 12/14 X 32MM Link America, Inc. | LZO |
| Mar 28, 1994 | K931572 | LINK CERAMIC HEADS 14/16 X 32MM Link America, Inc. | LZO |
| May 18, 1992 | K920756 | FELDMUHLE CERAMIC HEAD Link America, Inc. | LZO |
| Apr 29, 1992 | K914804 | RADIUS OSTEOTOMY PLATES Link America, Inc. | HRS |
| Apr 28, 1992 | K914803 | SCHWABE RADIUS PLATES Link America, Inc. | HRS |
| Mar 13, 1990 | K895507 | LINK GIEBEL BLADE PLATE SYSTEM Link America, Inc. | KTT |
| Sep 16, 1987 | K873507 | LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM Link America, Inc. | JDR |
| May 14, 1987 | K871535 | SMILJANIC BONE REPOSITIONING FORCEPS Link America, Inc. | HTD |
| Mar 5, 1986 | K854935 | LINK METAL-BACKED ACETABULAR CUPS Link America, Inc. | JDL |
| Feb 10, 1986 | K854465 | LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM Link America, Inc. | JDI |
| Jan 21, 1986 | K854825 | LINK SMALL BONE PLATES Link America, Inc. | HRS |
| Jan 21, 1986 | K853704 | LINK DYNAMIC STAPLE Link America, Inc. | JDR |
| Dec 27, 1985 | K854827 | LINK CORTICAL SCREWS Link America, Inc. | HWC |
| Dec 27, 1985 | K854826 | LINK CANCELLOUS SCREWS Link America, Inc. | HWC |
| Dec 16, 1985 | K852365 | LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM Link America, Inc. | KWS |
| Jun 18, 1985 | K852369 | LIDGRER-LUND ACETABULAR SOCKETS Link America, Inc. | JDL |
| Mar 23, 1984 | K840423 | HARRINGTON-TYPE INSTRU-SCOLIOSIS Link America, Inc. | KWP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||