Q Interbody Instruments

510(k) Number

K252873 ↗

FDA product code

OLO

Device class

Class II

Regulation

21 CFR Part 882.4560

Advisory committee

Neurology

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 OLO (Orthopedic Stereotaxic Instrument).

• 9734664 by Medtronic Navigation Inc.
• Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor by Stryker Leibinger GmbH & Co.KG
• Navbit Sprint System – Supine Registration, Navbit Sprint Kit – Lateral Registration by NAVBIT PTY LTD
• Navigated INFINITY Instruments by MEDTRONIC SOFAMOR DANEK, INC.
• CD HORIZON® Spinal System RBT011011 by MEDTRONIC SOFAMOR DANEK, INC.
• ORTHALIGN PLUS SYSTEM by Orthalign, Inc.
• SPINEART Navigation Instrument System by Spineart
• Mako Shoulder Application (1.0) by MAKO Surgical Corp.
• TSolution One w/ACG+ Surgical System by Think Surgical Inc.
• Mako Partial Knee Application by MAKO Surgical Corp.

• MESA® Spinal System

  Class I

  CE/MDR

• ALEUTIAN® Interbody Systems

  Class I

  CE/MDR

• EVEREST® Spinal System

  Class I

  CE/MDR

• CAYMAN® Plate System

  Class I

  CE/MDR

See all devices from K2M, Inc. →