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510(k) K113752

METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET by Solana Surgical, LLC — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2012
Date Received
December 21, 2011
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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  • 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)
  • K090127 — METATARSAL DECOMPRESSION IMPLANT, MODEL 100 (May 1, 2009)

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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)