PACP System

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

510(k) Number

K053053 ↗

FDA product code

KWQ

Device class

Class II

Regulation

21 CFR Part 888.3060

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

• Pacp

  Class II

  FDA 510(k) K083663 Active Cleared 25 Feb 2009

• Modification to: Pioneer Surgical Technology Quantum Spinal System

  Class II

  FDA 510(k) K070551 Active Cleared 29 Mar 2007

• Tritium Sternal Cable Plate System

  Class II

  FDA 510(k) K193468 Active Cleared 12 Mar 2020

• Pioneer Vertebral Spacer (Vertebral Spacer)

  Class II

  FDA 510(k) K061151 Active Cleared 24 Jul 2006

• Quantum/ Streamline Spinal System Model 02-Series and 10-Series

  Class II

  FDA 510(k) K093692 Active Cleared 11 Aug 2010

• Quantum/Streamline Tl Mis Spinal System

  Class II

  FDA 510(k) K093771 Active Cleared 10 Aug 2010

See all devices from Pioneer Surgical Technology, Inc. →

• What is the primary clinical purpose of the PACP System?

  The PACP System is designed for anterior cervical spinal fixation. It provides mechanical support to the cervical spine to facilitate fusion in patients who have degenerative, traumatic, or structural spinal conditions.

• What components are included in the PACP System?

  The system consists of metallic plates and screws used for fixation, along with the manual surgical instruments required for the implantation procedure.

• What is the regulatory status of this device?

  The PACP System is identified by FDA 510(k) number K053053. It has been determined to be substantially equivalent to other devices and is classified as an orthopedic appliance.