AMSET Locking Plate System

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

510(k) Number

K905023 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Amset Pld System

  Class II

  FDA 510(k) K905014 Active Cleared 1 Apr 1991

• Amsen Hockey Stick Chisel

  Class I

  FDA 510(k) K921644 Active Cleared 3 Jun 1992

• Cohort Bone Brush

  Class I

  FDA 510(k) K942108 Active Cleared 11 Oct 1994

• Amset(Tm) Cannulated Bone Screw

  Class II

  FDA 510(k) K931538 Active Cleared 4 May 1994

• Amset Bone Screw

  Class II

  FDA 510(k) K911768 Active Cleared 4 Oct 1991

• Amsen Posterior Disc Evacuator

  Class I

  FDA 510(k) K921643 Active Cleared 3 Jun 1992

See all devices from Advanced Med/Surg, Inc. →

• What is the AMSET Locking Plate System used for?

  The AMSET Locking Plate System is designed for internal stabilization of long bone fractures. It uses locking plates and screws to maintain rigid fixation, ensuring secure alignment and promoting proper bone healing by preventing displacement during the recovery process.

• Is the AMSET Locking Plate System sterile and single-use?

  Yes, the AMSET Locking Plate System is supplied sterile and intended for single-use in surgical settings. This ensures patient safety by preventing cross-contamination and maintaining sterile conditions during orthopedic procedures.

• What types of fracture patterns does the AMSET Locking Plate System accommodate?

  The system includes various plate and screw configurations tailored to different fracture patterns and anatomical sites. This modular design allows surgeons to select the appropriate components for optimal fixation and stability.

• How should the AMSET Locking Plate System be stored?

  Storage must follow the sterile packaging instructions provided by Advanced Med/Surg, Inc. Proper handling ensures the system remains uncontaminated and ready for surgical use, maintaining its integrity for safe application.

• What regulatory pathway was used for FDA clearance of the AMSET Locking Plate System?

  The AMSET Locking Plate System received FDA clearance under the Traditional review pathway, specifically under the 510(k) process. It was deemed Substantially Equivalent to a predicate device, ensuring compliance with orthopedic device standards.