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510(k) K191636

APTUS Foot System by Medartis AG — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2019
Date Received
June 19, 2019
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 Medartis AG

  • K243610 — APTUS Hand System; APTUS Elbow Dorsal Olecranon (March 7, 2025)
  • K240613 — APTUS Elbow Dorsal Olecranon Plates (June 20, 2024)
  • K232105 — APTUS Foot System 2.8-3.5 (April 19, 2024)
  • K234062 — APTUS Hand Scaphoid Plates (March 21, 2024)
  • K232251 — APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Ext (November 3, 2023)
  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)
  • K232144 — Sterile Products of the APTUS System (August 18, 2023)
  • K230971 — APTUS® 3.5 TriLock Straight Plates (June 2, 2023)
  • K223853 — Medartis APTUS® Ulna Plates (March 30, 2023)
  • K202589 — APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, (November 6, 2020)

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)