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510(k) K062040

SBI TRIHEDRON MTP HEMI GT by Small Bone Innovations, Inc. — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2006
Date Received
July 19, 2006
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 Small Bone Innovations, Inc.

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  • K112982 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) (April 2, 2012)
  • K102180 — RHEAD RADIAL HEAD EXTENDED STEMS (December 20, 2010)
  • K092754 — SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 (January 19, 2010)
  • K093550 — MINI RAIL EXTERNAL FIXATOR SYSTEM (January 7, 2010)
  • K073635 — SBI SR MTP TOE IMPLANT (March 19, 2008)
  • K071541 — SBI TWISTOFIX (September 10, 2007)
  • K063635 — SBI FOREFOOT SET (August 29, 2007)
  • K071656 — SBI ARTFIX (August 27, 2007)
  • K071540 — SBI TITANIUM THREADED PIN (August 8, 2007)

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)
  • K152454 — HemiCAP MTP Resurfacing Hemi-Arthroplasty System (April 11, 2016)