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510(k) K852365

LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM by Link America, Inc. — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1985
Date Received
June 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Other clearances by Link America, Inc.

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  • 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)

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