Medical device licence · 110332 · Class 3
PEDIATRIC NAILING PLATFORM | TIBIA
Yes: licensed in Canada
Licence status Issued (active); first licensed November 6, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110332
- Licence holder
- Orthopediatrics CorporationWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 6, 2023
- Devices covered
- 34
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ATTACHMENT BOLT
- ATTACHMENT BOLT-STERILE
- BALL HEX DRIVER, ZH QC
- BALL-TIPPED GUIDE WIRE
- CONICAL EXTRACTOR
- CONICAL REAMER
- INSERTION HANDLE
- K-WIRE, THREADED
- M7X1 CONICAL EXTRACTOR-STERILE
- MONOBLOC NITINOL REAMER
- NITINOL FLEX SHAFT
- PNP FULLY THREADED SCREW, TI
- PNP FULLY THREADED SCREW, TI-STERILE
- PNP NAIL DEPTH GAUGE, OUTER SLEEVE ASSEMBLY
- PNP NAIL DEPTH GAUGE, SCALE ASSEMBLY
- PNP RETAINING END CAP DRIVER, ZH QC
- PNP TIBIA CANNULATED END CAP
- PNP TIBIA CANNULATED END CAP FLUSH
- PNP TIBIA CANNULATED END CAP FLUSH-STERILE
- PNP TIBIA CANNULATED END CAP-STERILE
- PNP TIBIA NAIL
- PNP TIBIA NAIL MEASUREMENT TOOL
- PNP TIBIA NAIL-STERILE
- PROXIMAL TIBIAL PUNCH-STERILE
- SCREWDRIVER
- SUPRAPATELLAR ATTACHMENT BOLT
- SUPRAPATELLAR ATTACHMENT BOLT-STERILE
- SUPRAPATELLAR INSERTION HANDLE
- SUPRAPATELLAR LOW PROFILE PIN GUIDE
- SUPRAPATELLAR PARALLEL PIN GUIDE
- SUPRAPATELLAR SOFT SLEEVE
- SUPRAPATELLAR SOFT SLEEVE-STERILE
- SUPRAPATELLAR TROCAR, SMALL
- TAPERED SCREW DRIVER ZH QC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.