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510(k) K152454

HemiCAP MTP Resurfacing Hemi-Arthroplasty System by Arthrosurface, Inc. — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2016
Date Received
August 28, 2015
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 Arthrosurface, Inc.

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  • K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System (October 15, 2020)
  • K190261 — BOSS Toe Fixation System (August 14, 2019)
  • K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System (June 14, 2018)
  • K173964 — OVOMotion Shoulder Arthroplasty System (April 18, 2018)
  • K172383 — Arthrosurface Bone Screws (December 22, 2017)
  • K170440 — KISSloc Suture System (May 3, 2017)
  • K170350 — ToeMATE® Hammertoe Correction System (March 3, 2017)
  • K162391 — AlignMATE™ Lapidus Arthrodesis System (February 21, 2017)
  • K161539 — Arthrosurface Bone Screws (June 30, 2016)

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