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510(k) K853704

LINK DYNAMIC STAPLE by Link America, Inc. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1986
Date Received
September 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
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)
  • 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)

Other clearances for product code JDR

  • K250712 — Linkt Compression Staple System (May 14, 2025)
  • K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System (April 11, 2025)
  • K243742 — Arthrex DynaNite Nitinol Staples (January 31, 2025)
  • K243658 — TMC Compression Implant System (December 26, 2024)
  • K242415 — TMC Compression Implant System (September 6, 2024)
  • K240212 — COGNiTiON™ Staple System (February 23, 2024)
  • K232990 — A’TOMIC™ Nitinol Fixation System (January 12, 2024)
  • K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (December 4, 2023)
  • K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit (October 19, 2023)
  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)