Link America, Inc.
Mchenry, IL, US
Link America, Inc. appears in FDA device records in Mchenry, IL. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Link America, Inc. between 1984 and 1997. The busiest year on record is 1985, with 4. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 4 |
| 1986 | 4 |
| 1987 | 2 |
| 1990 | 1 |
| 1992 | 3 |
| 1994 | 2 |
| 1996 | 3 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K972760 | LINK, ACETABULAR REVISION MESH CUP | JDJ | Substantially Equivalent | |
| K964458 | ELLIS EXTERNAL MINI-FIXATOR SYSTEM | KTT | Substantially Equivalent | |
| K955296 | LINK MP RECONSTRUCTION HIP | JDI | Substantially Equivalent | |
| K954186 | SLED UNICOMPARTMENT KNEE SYSTEM | HSX | Substantially Equivalent | |
| K931571 | LINK CERAMIC HEADS 12/14 X 32MM | LZO | Substantially Equivalent for Some Indications | |
| K931572 | LINK CERAMIC HEADS 14/16 X 32MM | LZO | Substantially Equivalent | |
| K920756 | FELDMUHLE CERAMIC HEAD | LZO | Substantially Equivalent | |
| K914804 | RADIUS OSTEOTOMY PLATES | HRS | Substantially Equivalent for Some Indications | |
| K914803 | SCHWABE RADIUS PLATES | HRS | Substantially Equivalent | |
| K895507 | LINK GIEBEL BLADE PLATE SYSTEM | KTT | Substantially Equivalent | |
| K873507 | LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM | JDR | Substantially Equivalent | |
| K871535 | SMILJANIC BONE REPOSITIONING FORCEPS | HTD | Substantially Equivalent | |
| K854935 | LINK METAL-BACKED ACETABULAR CUPS | JDL | Substantially Equivalent | |
| K854465 | LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM | JDI | Substantially Equivalent | |
| K854825 | LINK SMALL BONE PLATES | HRS | Substantially Equivalent | |
| K853704 | LINK DYNAMIC STAPLE | JDR | Substantially Equivalent | |
| K854827 | LINK CORTICAL SCREWS | HWC | Substantially Equivalent | |
| K854826 | LINK CANCELLOUS SCREWS | HWC | Substantially Equivalent | |
| K852365 | LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM | KWS | Substantially Equivalent | |
| K852369 | LIDGRER-LUND ACETABULAR SOCKETS | JDL | Substantially Equivalent | |
| K840423 | HARRINGTON-TYPE INSTRU-SCOLIOSIS | KWP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWPAppliance, Fixation, Spinal Interlaminal
- HTDForceps
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis
- HRSPlate, Fixation, Bone
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- HWCScrew, Fixation, Bone
- JDRStaple, Fixation, Bone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Link America, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Link America, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain