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510(k) K972760

LINK, ACETABULAR REVISION MESH CUP by Link America, Inc. — Product Code JDJ

K972760 is an FDA 510(k) premarket notification submitted by Link America, Inc. for the device "LINK, ACETABULAR REVISION MESH CUP". The FDA issued a decision of Substantially Equivalent on October 22, 1997. The device falls under product code JDJ (Mesh, Surgical, Acetabular, Hip, Prosthesis), a Class II device regulated under 21 CFR 878.3300. Link America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1997
Date Received
July 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Acetabular, Hip, Prosthesis
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

Other clearances by Link America, Inc.

  • K964458 — ELLIS EXTERNAL MINI-FIXATOR SYSTEM (December 9, 1996)
  • K955296 — LINK MP RECONSTRUCTION HIP (February 14, 1996)
  • K954186 — SLED UNICOMPARTMENT KNEE SYSTEM (January 26, 1996)
  • K931571 — LINK CERAMIC HEADS 12/14 X 32MM (April 19, 1994)
  • K931572 — LINK CERAMIC HEADS 14/16 X 32MM (March 28, 1994)
  • K920756 — FELDMUHLE CERAMIC HEAD (May 18, 1992)
  • K914804 — RADIUS OSTEOTOMY PLATES (April 29, 1992)
  • K914803 — SCHWABE RADIUS PLATES (April 28, 1992)
  • K895507 — LINK GIEBEL BLADE PLATE SYSTEM (March 13, 1990)
  • K873507 — LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM (September 16, 1987)

Other clearances for product code JDJ

  • K970957 — OSTEONICS RESTORATION ACETABULAR RING (June 3, 1997)
  • K963940 — EXETER MESH (February 13, 1997)
  • K962541 — REFLECTION ACETABULAR REINFORCEMENT RINGS (September 17, 1996)
  • K962007 — PROTRUSION CAGES (August 1, 1996)
  • K925883 — OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS (June 15, 1993)
  • K890450 — INTERMEDICS APR(TM) II FEMORAL COMPONENT (August 9, 1989)

FDA data resources