ApprovalTrail

Medical device licence · 60647 · Class 3

CONGRUENT BONE PLATE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed October 4, 2002. It is in Health Canada’s list of active licences.
Licence number
60647
Licence holder
Acumed, LlcHillsboro, OR, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
October 4, 2002
Devices covered
25

Devices on this licence

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

  • CANCELLOUS SCREW
  • CONGRUENT BONE PLATE SYSTEM - CLAVICLE PLATE
  • CONGRUENT BONE PLATE SYSTEM - CORONOID PLATE
  • CONGRUENT BONE PLATE SYSTEM - DEPTH GAUGE
  • CONGRUENT BONE PLATE SYSTEM - DISTAL FIBULA PLATES
  • CONGRUENT BONE PLATE SYSTEM - DISTAL RADIUS PLATE
  • CONGRUENT BONE PLATE SYSTEM - DRILL
  • CONGRUENT BONE PLATE SYSTEM - GLIDE PLATES
  • CONGRUENT BONE PLATE SYSTEM - LATERAL EPICONDYAL PLATE
  • CONGRUENT BONE PLATE SYSTEM - MALLEOLAR
  • CONGRUENT BONE PLATE SYSTEM - MEDIAL EPICONDYAL PLATE
  • CONGRUENT BONE PLATE SYSTEM - METATARSOPHALANGEAL PLATES
  • CONGRUENT BONE PLATE SYSTEM - MIDSHAFT COMPRESSION PLATE
  • CONGRUENT BONE PLATE SYSTEM - OLECRANON PLATE
  • CONGRUENT BONE PLATE SYSTEM - OSTEOTOMY SAW BLADE
  • CONGRUENT BONE PLATE SYSTEM - POSTERIOR PLATE
  • CONGRUENT BONE PLATE SYSTEM - PROXIMAL FIRST METATARSAL OSTEOTOMY
  • CONGRUENT BONE PLATE SYSTEM - TAP ASSEMBLY
  • CONGRUENT BONE PLATE SYSTEM - TITANIUM GUIDE WIRE
  • CONGRUENT BONE PLATE SYSTEM - VOLAR RADIUS PLATE
  • CONGRUENT BONE PLATE SYSTEM - WRIST FUSION PLATE
  • CONGRUENT BONE PLATE SYSTEM- DRILL GUIDE
  • CONGRUENT BONE PLATE SYSTEM- MCP FUSION PLATES
  • CONGRUENT BONE PLATE SYSTEM- REAMER
  • CORTICAL SCREW

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