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510(k) K173491

RTS Lesser MTP Implant System by In2bones USA, LLC — Product Code KWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2018
Date Received
November 13, 2017
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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  • K153609 — RTS Flexible 1 MPJ Implant w/Grommets (September 8, 2016)
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  • 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)