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510(k) K201393

restor3d MTP Implant by Restor3D, Inc. — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2022
Date Received
May 27, 2020
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

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Other clearances for product code KWD

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  • 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)
  • K131377 — HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT (November 19, 2013)