Nuvasive Maxcess Light Guide

510(k) Number

K042034 ↗

FDA product code

FST

Device class

Class II

Regulation

21 CFR Part 878.4580

Advisory committee

General, Plastic Surgery

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 FST (Light, Surgical, Fiberoptic).

• LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES by Medical Illumination International, Inc
• ML-800 AUTOELECTRONIC LIGHT SOURCE by M.P. Video, Inc.
• INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM by INVUITY, INC.
• LITE WAND II by Thompson Surgical Instruments, Inc.
• OPHTHALMIC LIGHT PIPE PICK by Trek Medical Products, Inc.
• AXXION LIGHT GUIDE by SPINAL ELEMENTS, INC.
• END-IRRIGATING ENDOILLUMINATOR by Infinitech, Inc.
• ISOLED AC-POWERED LED HEADLIGHT SYSTEM by Isolux, LLC
• NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON by Nextec Corp.
• UltraLite® AX1375BIF by INTEGRA LIFESCIENCES (IRELAND) LIMITED

• Pulse

  Class I

  CE/MDR GUDID on market

• NuVasive CoRoent System

  Class II

  FDA 510(k) K043405 Active Cleared 7 Feb 2005

• NuVasive CoRoent Titanium System

  Class II

  FDA 510(k) K120918 Active Cleared 28 Jun 2012

• Modification to Nuvasive Neurovision Jjb System

  Class II

  FDA 510(k) K062765 Active Cleared 24 Jan 2007

See all devices from Nuvasive, Inc. →