ApprovalTrail

Medical device licence · 76917 · Class 3

CRANIAL FIXATION SCREWS

No longer licensed: cancelled: renewal not answered

Licence status Cancelled: renewal not answered; first licensed May 1, 2008; ended October 31, 2018. It is in Health Canada’s archive of licences no longer in force.
Licence number
76917
Licence holder
Bioplate IncLos Angeles, CA, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
May 1, 2008
Ended
October 31, 2018
Devices covered
18

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • BIOPLATE 1.0MM CRANIAL FIXATION SCREWS
  • BIOPLATE 1.2MM CRANIAL FIXATION SCREWS
  • BIOPLATE 1.2MM EMERGENCY CRANIAL FIXATION SCREWS
  • BIOPLATE 1.4MM CRANIAL FIXATION SCREWS
  • BIOPLATE 1.5MM CRANIAL FIXATION SCREWS
  • BIOPLATE 1.5MM CRANIAL FIXATION SCREWS PARTIAL THREAD
  • BIOPLATE 1.5MM CRANIAL SELF-DRILLING LOW PROFILE SCREWS
  • BIOPLATE 1.5MM SELF-DRILLING CRANIAL FIXATION SCREWS
  • BIOPLATE 1.5MM SELF-DRILLING CRANIAL FIXATION SCREWS, STERILE
  • BIOPLATE 1.8MM CRANIAL FIXATION SCREWS
  • BIOPLATE 1.8MM EMERGENCY CRANIAL FIXATION SCREWS
  • BIOPLATE 1.9MM CRANIAL FIXATION SCREWS
  • BIOPLATE 1.9MM CRANIAL FIXATION SELF-DRILLING SCREWS
  • BIOPLATE 1.9MM CRANIAL FIXATION SELF-DRILLING SCREWS, STERILE
  • BIOPLATE 2.0 PARTIALLY THREADED CRANIAL FIXATION SCREWS
  • BIOPLATE 2.0MM CRANIAL FIXATION SCREWS
  • BIOPLATE BIO-100 1.5MM CRANIAL FIXATION SCREWS
  • BIOPLATE XPRESS CRANIAL SCREWS

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.