Home / 510(k) Clearances / K153609

510(k) K153609

RTS Flexible 1 MPJ Implant w/Grommets by In2bones USA, LLC — Product Code KWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2016
Date Received
December 17, 2015
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

Other clearances by In2bones USA, LLC

  • K241387 — CoLink NeoFuse MIS Plating System (see attached parts list) (August 13, 2024)
  • K233089 — NeoSpan® Compression Implant System (May 24, 2024)
  • K231236 — IBS-B MIS Beveled Screw System (July 27, 2023)
  • K213698 — CoLink PCR Plating System (May 27, 2022)
  • K220260 — Hercules Syndesmosis Implant System (March 31, 2022)
  • K212872 — Avenger Radial Head System (December 17, 2021)
  • K213069 — CoLink NeoFuse Plating System (December 13, 2021)
  • K212487 — CoLink Vallux Plating System (November 18, 2021)
  • K203698 — CoLink Sfx Implant System (May 4, 2021)
  • K210060 — CoLink Mfx Implant System (March 12, 2021)

Other clearances for product code KWH

  • K191966 — NewPrim System (February 13, 2020)
  • K190136 — Fusion Silastic System (October 21, 2019)
  • K173491 — RTS Lesser MTP Implant System (February 23, 2018)
  • 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)