Endius Minit Posterior Cervical and Upper Thoracic Fixation System

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

510(k) Number

K073267 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Endius Flextip Blade

  Class II

  FDA 510(k) K022578 Active Cleared 23 Aug 2002

• Endius Minit Posterior Cervical and Upper Thoracic Fixation System

  Class II

  FDA 510(k) K060683 Active Cleared 18 Apr 2006

• Endius Spinal Fixation System

  Class II

  FDA 510(k) K014090 Active Cleared 11 Mar 2002

• Endius Title 2 Polyaxial Spinal System

  Class II

  FDA 510(k) K070367 Active Cleared 12 Apr 2007

• Endius Endoscopic Access System

  Class II

  FDA 510(k) K002437 Active Cleared 2 Oct 2000

• Endius Spine Endoscope

  Class II

  FDA 510(k) K982819 Active Cleared 27 Jan 1999

See all devices from Endius, Inc. →

• What is the Endius Minit Posterior Cervical and Upper Thoracic Fixation System used for?

  This system is specifically designed for posterior cervical and upper thoracic spine stabilization, promoting spinal fusion in the C1–T3 segments. It provides secure attachment to vertebrae, ensuring structural support and proper alignment during surgical procedures to address instability or degenerative conditions in these areas.

• Is the Endius Minit system single-use or reusable?

  The Endius Minit Posterior Cervical and Upper Thoracic Fixation System is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintains the integrity of the components for optimal performance in surgical settings.

• How should the system be stored to maintain sterility and functionality?

  Proper storage conditions are critical to preserve both sterility and functionality. The system must be stored in its original packaging, protected from moisture, heat, and physical damage. Follow manufacturer guidelines to ensure the device remains effective for its intended surgical use.

• Are the components of this fixation system MRI-safe?

  Yes, the components of the Endius Minit system are designed with MRI safety in mind where applicable. However, always verify compatibility with your specific MRI machine settings and protocols before use, as individual components may have varying levels of MRI safety.

• What regulatory clearance does this device hold?

  The Endius Minit Posterior Cervical and Upper Thoracic Fixation System holds FDA 510(k) clearance under the reference number K073267. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness.