Medical device licence · 10820 · Class 3
TRIGEN TITANIUM NAIL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 26, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 10820
- Licence holder
- Smith & Nephew, Inc.Mississauga, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 26, 1999
- Devices covered
- 35
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- META-TAN LAG SCREW TAP
- TRIGEN INTERTAN 10S NAIL
- TRIGEN INTERTAN NAIL
- TRIGEN L-P SCREW
- TRIGEN META-NAIL - COMPRESSION DRIVER
- TRIGEN META-NAIL - DISPOSABLE EXTRACTOR
- TRIGEN META-NAIL - NAIL CAP
- TRIGEN META-NAIL - RETROGRADE FEMORAL NAILS
- TRIGEN META-NAIL - TIBIAL NAILS
- TRIGEN META-TAN COMPRESSION SCREW
- TRIGEN META-TAN LAG/COMPRESSION SCREW KIT
- TRIGEN META-TAN SET SCREW
- TRIGEN META-TAN TROCHANTERIC ANTEGRADE NAIL
- TRIGEN SELF-TAPPING CANCELLOUS SCREW
- TRIGEN TITANIUM NAIL SYSTEM - ADOLESCENT TROCHANTERIC ANTEGRADE NAILS
- TRIGEN TITANIUM NAIL SYSTEM - CAPS
- TRIGEN TITANIUM NAIL SYSTEM - FEMORAL ANTEGRADE NAILS
- TRIGEN TITANIUM NAIL SYSTEM - FEMORAL INTERLOCKING NAILS
- TRIGEN TITANIUM NAIL SYSTEM - GUIDES
- TRIGEN TITANIUM NAIL SYSTEM - HINDFOOT FUSION NAIL
- TRIGEN TITANIUM NAIL SYSTEM - HUMERAL NAILS
- TRIGEN TITANIUM NAIL SYSTEM - INSTRUMENTATION
- TRIGEN TITANIUM NAIL SYSTEM - INTERNAL HEX CAPTURED SCREW
- TRIGEN TITANIUM NAIL SYSTEM - INTERNAL HEX RECON SCREWS
- TRIGEN TITANIUM NAIL SYSTEM - INTERTAN COMPRESSION SCREWS
- TRIGEN TITANIUM NAIL SYSTEM - INTERTAN LAG/COMP SCREW KIT
- TRIGEN TITANIUM NAIL SYSTEM - INTERTAN NAIL CAP
- TRIGEN TITANIUM NAIL SYSTEM - INTERTAN SET SCREW
- TRIGEN TITANIUM NAIL SYSTEM - INTERTAN SUBTROC LAG SCREWS
- TRIGEN TITANIUM NAIL SYSTEM - PROXIMAL HUMERAL NAILS
- TRIGEN TITANIUM NAIL SYSTEM - STABLE LOCK NUT AND WASHER
- TRIGEN TITANIUM NAIL SYSTEM - TRIGEN INTERTAN 1.5
- TRIGEN TITANIUM NAIL SYSTEM - TROCHANTERIC ANTEGRADE NAILS (TAN)
- TRIGEN XL SEMI EXTENDED EXTRACTION BOLT
- TRIGON TITANIUM NAIL SYSTEM - SELF-TAPPING CORTICAL SCREW
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “trigen”. A notice may cover another product or only some lots: read it to see what it covers.
- Trigen Titanium Nail System - Trochanteric Antegrade Nails (TAN)August 4, 2023 · Orthopaedics · Labelling and packaging · Type II
- Trigen Intertan NailsMay 3, 2022 · Orthopaedics · Manufacturing defect · Type II
- TRIGEN TITANIUM NAIL SYSTEM - INTERNAL HEX RECON SCREWS (2016-07-19)July 29, 2016 · Medical devices · Medical devices · Type III
- Trigen Titanium Nail System - Intertan Short Nail (2014-07-07)July 22, 2014 · Medical devices · Medical devices · Type II
- Trigen Titanium Nail System - Intertan Short Nails (2014-04-07)June 5, 2014 · Medical devices · Medical devices · Type II
- Trigen Titanium Nail System - Intertan Short NailsFebruary 4, 2013 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.