Alta Cfx Rod System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K926232 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Howmedica(R) Fully Threaded Screws

  Class II

  FDA 510(k) K974720 Active Cleared 13 Mar 1998

• Alta Femoral Intramedullary Rods/Cfx Rods Modification

  Class II

  FDA 510(k) K935295 Active Cleared 11 Oct 1994

• Naso-Gard Nasogastric Tube Holder

  Class II

  FDA 510(k) K801511 Active Cleared 28 Jul 1980

• Class of Casting Alloys Type III or Alt

  Class II

  FDA 510(k) K820434 Active Cleared 11 Mar 1982

• Howmedica Zirconia Ceramic Femoral Head

  Class II

  FDA 510(k) K945090 Active Cleared 19 Jan 1995

• Extended Balljoint Grip

  Class II

  FDA 510(k) K802723 Active Cleared 19 Nov 1980

See all devices from Howmedica Corp. →

• What is the primary clinical purpose of the Alta Cfx Rod System?

  The Alta Cfx Rod System is an orthopedic device intended for internal fixation. It is specifically designed to provide the necessary structural support and stabilization required for bone segments during the healing process.

• What is the regulatory status of this device?

  The Alta Cfx Rod System is classified as an FDA class 2 medical device. It has received authorization under FDA 510(k) clearance number K926232, which indicates it has been found substantially equivalent to legally marketed predicate devices.

• Who is the manufacturer of the Alta Cfx Rod System?

  The device is manufactured by Howmedica Corp., located in Rutherford, New Jersey. The company submitted the device for regulatory review, resulting in its clearance under the traditional 510(k) pathway.