Medical device licence · 76504 · Class 3
DARCO SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 6, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76504
- Licence holder
- Wright Medical Technology, IncArlington, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 6, 2008
- Devices covered
- 35
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DARCO BENDING IRON
- DARCO DEPTH GAUGE
- DARCO DRILL GUIDE
- DARCO HEADED DEPTH GAUGE
- DARCO HEADED DRILL SLEEVE
- DARCO HEADLESS COMPRESSION SCREW
- DARCO HEADLESS SCREW, LONG THREAD
- DARCO HEADLESS SCREW, SHORT THREAD
- DARCO SYSTEM - 7.0 HEADLESS SCREW NON-STERILE
- DARCO SYSTEM - 7.0 HEADLESS SCREW STERILE
- DARCO SYSTEM - 7.0 SCREW WASHER NON-STERILE
- DARCO SYSTEM - 7.0 SCREW WASHER OBLIQUE NON-STERILE
- DARCO SYSTEM - 7.0 SCREW WASHER OBLIQUE STERILE
- DARCO SYSTEM - 7.0 SCREW WASHER STERILE
- DARCO SYSTEM - AFP PLATE
- DARCO SYSTEM - BOW II OPENING WEDGE
- DARCO SYSTEM - BOW II OPENING WEDGE, STERILE
- DARCO SYSTEM - BOW OPENING WEDGE PLATE
- DARCO SYSTEM - CPS CALCANEAL PLATE
- DARCO SYSTEM - DPS STEP PLATE
- DARCO SYSTEM - HEADED SCREW
- DARCO SYSTEM - LPS PLATE
- DARCO SYSTEM - MODULAR FOREFOOT IMPLANT KIT
- DARCO SYSTEM - MODULAR REARFOOT IMPLANT KIT
- DARCO SYSTEM - MPJ PLATE
- DARCO SYSTEM - PIA PLATE
- DARCO SYSTEM - RPS PLATE
- DARCO SYSTEM - SCREW WASHER
- DARCO SYSTEM - TI LOCK SCREW 2.7 MM
- DARCO SYSTEM - TI LOCK SCREW 3.5 MM
- DARCO SYSTEM - TI NON-LOCK SCREW 2.7 MM
- DARCO SYSTEM - TI NON-LOCK SCREW 3.5 MM
- DARCO SYSTEM - TOM PLATE
- DARCO SYSTEM - UPS 2.7 MM PLATE
- DARCO SYSTEM - UPS 3.5 MM LOCK PLATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.