Summit Occipito-Cervico- Thoracic (Oct) Spinal System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K013222 ↗

FDA Product Code

MNI

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Moss Miami Spinal Systems

  Class II

  FDA 510(k) K013296 Active Cleared 9 Oct 2001

• Monarch Spine System

  Class II

  FDA 510(k) K021335 Active Cleared 11 Jul 2002

• Eagle Anterior Cervial Plate System

  Class II

  FDA 510(k) K040197 Active Cleared 2 Apr 2004

• Stackable Cage System

  Class II

  FDA 510(k) K001340 Active Cleared 26 Jul 2000

• Depuy Acromed Vbr System

  Class II

  FDA 510(k) K030833 Active Cleared 10 Apr 2003

• Crossover Cross Connector (Moss Miami Spine System)

  Class II

  FDA 510(k) K021880 Active Cleared 26 Jun 2002

See all devices from Depuyacromed →

• What is the Summit OCT Spinal System used for?

  The Summit Occipito-Cervico-Thoracic (OCT) Spinal System is intended for use in posterior spinal fusion procedures involving the occipito-cervico-thoracic junction, providing stabilization through rods, plates, bone screws, and connectors.

• How is the Summit OCT Spinal System supplied?

  The device is supplied as a spinal fixation system containing components such as rods, plates, nuts, bolts, washers, bone screws, transverse rod connectors, cable connectors, and Songer Cables for surgical assembly.

• Is the Summit OCT Spinal System reusable or single-use?

  The system is composed of implantable components such as bone screws, rods, and plates, which are intended for single-use implantation during posterior spinal fusion procedures and are not designed for reuse.

• What regulatory pathway was used for the Summit OCT Spinal System?

  The device received FDA 510(k) clearance (K013222) on November 7, 2001, and was determined to be substantially equivalent to a predicate device under product code MNI.

• What materials or components make up the Summit OCT Spinal System?

  The system includes rods, plates, nuts, bolts, washers, bone screws, transverse rod connectors, cable connectors, and Songer Cables, all intended for posterior spinal fixation in occipito-cervico-thoracic fusion.