Home / 510(k) Clearances / K191966

510(k) K191966

NewPrim System by Brm Extremities — Product Code KWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2020
Date Received
July 23, 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

Other clearances by Brm Extremities

  • K220142 — BRM Digitalis Spacer (April 4, 2023)
  • K222820 — BRM TOOL Screws, BIOPLAN Subtalar Implant (December 16, 2022)
  • K203773 — BRM TOOL Screws (January 14, 2022)

Other clearances for product code KWH

  • K190136 — Fusion Silastic System (October 21, 2019)
  • 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)