ApprovalTrail

Medical device licence · 69288 · Class 4

BONE ALLOGRAFT (SKELETAL)

No longer licensed: suspended: invalid quality-system certificate

Licence status Suspended: invalid quality-system certificate; first licensed September 19, 2005; ended September 2, 2026. It is in Health Canada’s archive of licences no longer in force.
Licence number
69288
Licence holder
Rti Surgical, Inc.Alachua, FL, United States
Risk class
Class IV (highest risk)
Licence type
Device Family
First licensed
September 19, 2005
Ended
September 2, 2026
Devices covered
17

Devices on this licence

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

  • BIOSET ALLOGRAFT PASTE, SYRINGE
  • BIOSET IC ALLOGRAFT FULL DISC
  • BIOSET IC ALLOGRAFT PARTIAL DISC
  • BIOSET IC MOLDABLE ALLOGRAFT PASTE SYRINGE
  • BIOSET IC, RT ALLOGRAFT PASTE
  • BIOSET RT ALLOGRAFT PASTE, SYRINGE
  • OPTEFIL ALLOGRAFT PASTE
  • OPTEFIL ALLOGRAFT PASTE SYRINGE
  • OPTEFIL ALLOGRAFT, SYRINGE
  • OPTEFIL RT ALLOGRAFT PASTE
  • OPTEFORM ALLOGRAFT DISC
  • OPTEFORM ALLOGRAFT FULL DISC
  • OPTEFORM ALLOGRAFT PARTIAL DISC
  • OPTEFORM ALLOGRAFT PASTE
  • OPTEFORM ALLOGRAFT, RT
  • OPTEFORM MOLDABLE ALLOGRAFT PASTE
  • OPTEFORM RT ALLOGRAFT PASTE

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