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510(k) K131187

LESSER METATARSAL HEAD IMPLANT SYSTEM by Solana Surgical, LLC — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2013
Date Received
April 26, 2013
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 Solana Surgical, LLC

  • K132594 — CROSSCHECK PLATING SYSTEM (December 13, 2013)
  • K124045 — FUSEFORCE IMPLANT SYSTEM (July 10, 2013)
  • K122738 — GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET (November 7, 2012)
  • K120390 — SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET (April 10, 2012)
  • K120029 — HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET (February 6, 2012)
  • K113752 — METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET (February 6, 2012)
  • K090127 — METATARSAL DECOMPRESSION IMPLANT, MODEL 100 (May 1, 2009)

Other clearances for product code KWD

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  • K221220 — Montross Extremity Medical Hemi Implant System (April 19, 2023)
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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)