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R&R External Fixation System

by R&R Medical, Inc. 510(k)

Active United States

510(k) K052005

Overview

The R&R External Fixation System is an orthopedic device used for external fixation. It is indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, and limb lengthening.

The R&R External Fixation System is supplied with various components, including the R&R Ring Fixator. It is classified as a class 2 device with a product code of KTT and is regulated under 888.3030. The device has been cleared by the FDA with a Traditional 510(k) clearance, with a decision date of 2005-09-06.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052005 Date6 Sep 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KTT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from R&R Medical, Inc.

Questions

  • What is the R&R External Fixation System used for?

    The R&R External Fixation System is used for external fixation of open and closed fractures, pseudoarthrosis or nonunions of long bones, and limb lengthening, providing stability and support during the healing process.

  • How is the R&R External Fixation System supplied?

    The R&R External Fixation System is supplied with various components, including the R&R Ring Fixator, to provide a comprehensive system for external fixation.

  • Is the R&R External Fixation System a single-use or reusable device?

    The device description does not explicitly state whether the R&R External Fixation System is single-use or reusable, but it is classified as a class 2 device with a product code of KTT.

  • What regulatory clearance does the R&R External Fixation System have?

    The R&R External Fixation System has been cleared by the FDA with a Traditional 510(k) clearance, with a decision date of 2005-09-06, indicating that it is substantially equivalent to a predicate device.