Ogden Anchor-Small

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

Full name

Ogden Anchor-Small (Tentative)

510(k) Number

K941029 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Ame Universal Bone Screw

  Class II

  FDA 510(k) K930107 Active Cleared 22 Feb 1994

• Ame(R) Rigid Fixation System

  Class II

  FDA 510(k) K930531 Active Cleared 1 Feb 1994

• Ogden Anchor

  Class II

  FDA 510(k) K952348 Active Cleared 21 Aug 1995

• Ame(R) Universial Cable System

  Class II

  FDA 510(k) K932687 Active Cleared 3 May 1994

• Ame Universal Fixation System

  Class II

  FDA 510(k) K931381 Active Cleared 1 Feb 1995

• Ogden Anchor Additional Applications

  Class II

  FDA 510(k) K935065 Active Cleared 30 Jan 1995

See all devices from American Medical Electronics, Inc. →

• What types of spinal procedures is the Ogden Anchor-Small designed to support, and how does it provide stability during surgery?

  The Ogden Anchor-Small is specifically designed for internal fixation of spinal segments, offering stability through direct bone anchoring. It is used in orthopedic spinal procedures to secure vertebrae, ensuring proper alignment and immobilization during the healing process. Its purpose is to maintain stability in spinal segments where surgical intervention is required, such as fusions or corrections of spinal deformities.

• Is the Ogden Anchor-Small intended for reuse, or is it meant to be used only once? How does this affect its handling and storage?

  The Ogden Anchor-Small is explicitly intended for single-use only. This means it should not be cleaned, sterilized, or reused after a single surgical procedure. Because it is supplied sterile, proper handling and storage are critical to maintain sterility until use. It should be stored in a clean, dry environment, away from direct sunlight or extreme temperatures, to preserve its integrity for the intended single application.

• How is the regulatory status of the Ogden Anchor-Small determined, and what does this mean for its use in clinical settings?

  The Ogden Anchor-Small holds FDA 510(k) clearance under the classification K941029, determined as *Substantially Equivalent* to a predicate device. This means it has been reviewed and approved by the FDA as meeting the same performance standards as a previously cleared device in the same category (product code JDR). Clinically, this clearance indicates that the device adheres to safety and effectiveness requirements for orthopedic spinal fixation, allowing its use in approved surgical applications as described in the labeling.

• What are the key specifications or standards that the Ogden Anchor-Small adheres to, and why does this matter for purchasing decisions?

  The Ogden Anchor-Small complies with 21 CFR 888.3030, which outlines the performance and labeling requirements for spinal fixation devices. This regulatory adherence ensures consistency in manufacturing, safety, and functionality, which is critical for clinical outcomes. For purchasers, compliance with these standards validates the device’s reliability, traceability, and suitability for spinal orthopedic procedures, reducing risks associated with substandard or non-compliant implants.