Quantum Spinal System, Quantum Mis

510(k) Number

K101790 ↗

FDA product code

NKB

Device class

Class II

Regulation

21 CFR Part 888.3070

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code NKB (Thoracolumbosacral Pedicle Screw System).

• APEX Spine System M6-6225C by SPINECRAFT LLC
• Erisma®-LP 13028560 by Clariance, Inc.
• Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod by Stryker Spine
• Blackstone Pedicle Screw System by Blackstone Medical, Inc.
• Erisma™-LP 18015525 by Clariance, Inc.
• Duet™ Spinal Fixation System by Duet Spine Holdings, LLC
• Revolution Spinal Fixation System by INTELLIGENT IMPLANT SYSTEMS, LLC
• Nautilus Spinal System by Life Spine, Inc.
• Coral Spinal System by Theken Spine, LLC
• NuVasive Reline System by Nu Vasive, Incorporated

• 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

See all devices from Pioneer Surgical Technology, Inc. →