Device Recall XGuide Surgical Navigation System

  • Model / Serial
    Model Numbers: P007665 X-Clip; Component of System P007839. Note: P007665 X-Clip Component is distributed as X-Clip Bulk Kit PN P008381, package of 12 pieces P007665.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC.
  • Product Description
    X-Guide Surgical Navigation System, X-Clip Bulk Kit || The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    X-NAV Technologies, LLC, 1555 Bustard Rd Ste 75, Lansdale PA 19446-5731
  • Manufacturer Parent Company (2017)
  • Source
    USFDA