Home / 510(k) Clearances / K193491

510(k) K193491

restor3d Metallic Interference Screw by Restor3d — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2020
Date Received
December 17, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Restor3d

  • K252067 — Velora Acetabular System (December 5, 2025)
  • K252454 — Kinos Total Ankle System (September 3, 2025)
  • K243643 — restor3d Reverse Total Shoulder Arthroplasty System (May 19, 2025)
  • K243768 — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (March 27, 2025)
  • K242356 — TIDAL Fusion Cage System (March 24, 2025)
  • K242868 — Kinos Total Ankle System (October 18, 2024)
  • K241482 — Kinos Total Ankle System (July 22, 2024)
  • K240591 — restor3d Kinos Axiom Total Ankle System (April 29, 2024)
  • K234087 — restor3d TIDAL Lumbar Interbody Fusion System (January 22, 2024)
  • K232595 — Kinos Axiom Total Ankle System (November 28, 2023)

Other clearances for product code HWC

  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K252901 — Tyber Medical Trauma Screw (December 31, 2025)
  • K251555 — Ultra™ Compression Screw System (November 6, 2025)
  • K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (October 10, 2025)
  • K250536 — MetaFore Small Screw System (October 8, 2025)
  • K252758 — Cannulated Screw and Kirschner (K wire) System (October 2, 2025)
  • K252019 — CurvaFix Low Profile System (August 29, 2025)
  • K251382 — Phoenix Sinus Tarsi Stent System (August 27, 2025)
  • K250867 — Dunamis Screw and Suture Locking System (August 15, 2025)
  • K250251 — Eleganz Fusion Screw System (Fusion Screw System) (June 13, 2025)