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510(k) K190136

Fusion Silastic System by Fusion Orthopedics, LLC — Product Code KWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2019
Date Received
January 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe, Constrained, Polymer
Device Class
Class II
Regulation Number
888.3720
Review Panel
OR
Submission Type

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Other clearances for product code KWH

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  • K173491 — RTS Lesser MTP Implant System (February 23, 2018)
  • K153609 — RTS Flexible 1 MPJ Implant w/Grommets (September 8, 2016)
  • K102601 — ORTHOFLEX ROD (January 14, 2011)
  • K023531 — LESSER METATARSAL PHALANGEAL JOINT IMPLANT (January 17, 2003)
  • K022887 — INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (November 26, 2002)
  • K022886 — METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (November 25, 2002)
  • K023562 — MODIFICATION TO CLASSIC GREAT TOE IMPLANT (November 13, 2002)
  • K023086 — CLASSIC GREAT TOE IMPLANT (October 4, 2002)
  • K994326 — ASCENT KNEE SYSTEM (January 7, 2000)