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510(k) K071243

METAL HEMI IMPLANT by Orthopro, LLC — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2007
Date Received
May 3, 2007
Clearance Type
Special
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)
  • K062908 — ORTHROPRO HEMI TOE (November 13, 2006)

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  • 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)