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510(k) K931571

LINK CERAMIC HEADS 12/14 X 32MM by Link America, Inc. — Product Code LZO

Clearance Details

Decision
SN ()
Decision Date
April 19, 1994
Date Received
March 30, 1993
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)
  • 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)

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