Home / 510(k) Clearances / K203475

510(k) K203475

LimaCorporate Kirschner Wire by Lima Corporate S.P.A. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2021
Date Received
November 25, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Lima Corporate S.P.A.

  • K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (January 22, 2026)
  • K251718 — ArTT Augments and Buttresses and Bone Screws (August 29, 2025)
  • K243826 — SMR Reverse HP Shoulder System (July 3, 2025)
  • K250980 — Physica System (Physica CR Porous Femoral components) (May 22, 2025)
  • K243615 — Physica Porous Femoral Components (December 18, 2024)
  • K234011 — AMF TT Cones (January 18, 2024)
  • K233712 — PRIMA Humeral System; PRIMA TT Glenoid (January 11, 2024)
  • K231099 — SMR Hybrid Glenoid System (December 21, 2023)
  • K231925 — MINIMA S System (July 11, 2023)
  • K221758 — SMR Stemless Anatomic (March 17, 2023)

Other clearances for product code HTY

  • K253325 — ZipToe™ Hammertoe Fusion System (December 29, 2025)
  • K252657 — Impact PEEK Union Nail System (September 19, 2025)
  • K250315 — RONAVIS – FX (FX-001) (August 1, 2025)
  • K251362 — PediFlex™ Flexible Nail System (June 24, 2025)
  • K250646 — Impact PEEK Union Nail System (June 11, 2025)
  • K241014 — Biomet Kirschner Wires (K-Wires) (May 22, 2024)
  • K231272 — OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimm (December 1, 2023)
  • K231147 — Hammerdesis™ Interphalangeal Fusion System (September 14, 2023)
  • K230750 — OSSIOfiber® Cannulated Trimmable Fixation Nail (September 13, 2023)
  • K231905 — Electro-Spec Steri-Caps (August 14, 2023)