Alta Fully Threaded Cross-Locking Screws

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

510(k) Number

K963398 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

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 are the Alta Fully Threaded Cross-Locking Screws used for?

  These screws are orthopedic fixation components designed for the static and dynamic locking of intramedullary rods. They are specifically intended to facilitate the repair of femoral, tibial, and humeral fractures.

• Which systems are these screws compatible with?

  The screws are designed for use in conjunction with the Alta Femoral and Alta Tibial/Humeral Intramedullary Rod Systems. They are intended for application in clinical or operating room settings.

• What is the size and drive type of this device?

  The Alta Fully Threaded Cross-Locking Screws are available in a 5.0 mm size. They feature a T25 standard drive hex head to facilitate the surgical procedure.

• What is the regulatory status of this device?

  The Alta Fully Threaded Cross-Locking Screws have received FDA 510(k) clearance under product code HWC. This classification identifies them as bone fixation screws.