Medical Device Manufacturer · US , Mchenry , IL

Link America, Inc. - FDA 510(k) Cleared Devices

21 submissions · 19 cleared · Since 1984

Recent clearances: LINK, ACETABULAR REVISION MESH CUP, ELLIS EXTERNAL MINI-FIXATOR SYSTEM, LINK MP RECONSTRUCTION HIP

21

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Link America, Inc. Orthopedic ✕

20 devices

1-12 of 20

Cleared Oct 22, 1997

LINK, ACETABULAR REVISION MESH CUP

Orthopedic · 90d

Cleared Dec 09, 1996

ELLIS EXTERNAL MINI-FIXATOR SYSTEM

Orthopedic · 32d

Cleared Feb 14, 1996

LINK MP RECONSTRUCTION HIP

Orthopedic · 90d

Cleared Jan 26, 1996

SLED UNICOMPARTMENT KNEE SYSTEM

Orthopedic · 142d

Cleared Apr 19, 1994

LINK CERAMIC HEADS 12/14 X 32MM

Orthopedic · 385d

Cleared Mar 28, 1994

LINK CERAMIC HEADS 14/16 X 32MM

Orthopedic · 363d

Cleared May 18, 1992

FELDMUHLE CERAMIC HEAD

Orthopedic · 89d

Cleared Apr 29, 1992

RADIUS OSTEOTOMY PLATES

Orthopedic · 188d

Cleared Apr 28, 1992

SCHWABE RADIUS PLATES

Orthopedic · 187d

Cleared Mar 13, 1990

LINK GIEBEL BLADE PLATE SYSTEM

Orthopedic · 183d

Cleared Sep 16, 1987

LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM

Orthopedic · 16d

Cleared Mar 05, 1986

LINK METAL-BACKED ACETABULAR CUPS

Orthopedic · 85d