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510(k) K062908

ORTHROPRO HEMI TOE by Orthopro, LLC — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2006
Date Received
September 27, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe, Hemi-, Phalangeal
Device Class
Class II
Regulation Number
888.3730
Review Panel
OR
Submission Type

Other clearances by Orthopro, LLC

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  • K113006 — I-FUSE HAMMER TOE SYSTEMS (May 25, 2012)
  • K093055 — CSTS SCREW (November 22, 2010)
  • K073228 — DC ULNAR SHORTENING SYSTEM (February 29, 2008)
  • K070555 — ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES (July 13, 2007)
  • K071243 — METAL HEMI IMPLANT (May 23, 2007)

Other clearances for product code KWD

  • K240268 — Accu-Joint Hemi Implant (February 29, 2024)
  • K221220 — Montross Extremity Medical Hemi Implant System (April 19, 2023)
  • K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant (November 22, 2022)
  • K201393 — restor3d MTP Implant (May 25, 2022)
  • K203634 — BioPoly Great Toe Hemiarthroplasty Implant (February 2, 2021)
  • K200951 — Accu-Joint Hemi Implant (December 8, 2020)
  • K190261 — BOSS Toe Fixation System (August 14, 2019)
  • K190543 — Cannulated Hemi Implant (May 31, 2019)
  • K161279 — Life Spine Metatarsal Hemi Implant (February 1, 2017)
  • K152454 — HemiCAP MTP Resurfacing Hemi-Arthroplasty System (April 11, 2016)