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510(k) K920756

FELDMUHLE CERAMIC HEAD by Link America, Inc. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1992
Date Received
February 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Link America, Inc.

  • K972760 — LINK, ACETABULAR REVISION MESH CUP (October 22, 1997)
  • 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)
  • 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)

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