ApprovalTrail

Medical device licence · 85512 · Class 2

TRIALS - PLASTIC

Yes: licensed in Canada

Licence status Issued (active); first licensed March 18, 2011. It is in Health Canada’s list of active licences.
Licence number
85512
Licence holder
Howmedica Osteonics CorporationMahwah, NJ, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
March 18, 2011
Devices covered
90

Devices on this licence

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

  • 127 DEGREE C-TAPER TRIAL NECK
  • ADM MONOPOLAR TRIAL INSERT
  • ADM/MDM MONOPOLAR TRIAL INSERT
  • ARTICULATING TRIAL HEAD
  • AVON-PATELLO-FEMORAL JOINT, TRIAL PATELLA COMPONENT
  • BI-POLAR TRIAL HEAD
  • BIOPOLAR / UNIPOLAR TRIAL
  • C-TAPER FEMORAL HEAD TRIAL
  • C-TAPER SLEEVE TRIAL FOR ADM/MDM
  • C-TAPER HIP FRACTURE UNITRAX C-TAPER TRIAL GAUGE EXTENSION
  • CENTRAX BIPOLAR TRIAL ADAPTOR
  • CENTRAX BIPOLAR TRIAL/GAUGE REPLACEMENT ADAPTOR
  • CENTRAX TRIAL/GAUGE SHELL
  • CENTRAX BIPOLAR TRIAL INSERT
  • DC MOBILE TRIAL SPACER
  • DURACON PATELLA TRIAL
  • DURACON TOTAL KNEE TIBIAL INSERT TRIAL - CONSTRAINED
  • DURACON TRIAL
  • DURATION TRIAL TIBIAL INSERT
  • EIUS UNI TIBIAL INSERT TRIAL
  • EIUS UNI TIBIAL INSERT TRIAL
  • EIUS UNI TRIAL TIBIAL
  • ENDO TRIAL HEAD
  • ENDO TRIAL HEAD C-TAPER
  • FEMORAL TRIAL
  • HOWMEDICA ANATOMIC SHOULDER TRIAL
  • HUMERAL BEAR, HEAD TRIAL
  • HUMERAL TRIAL INSERT
  • INSERT TRIAL
  • INT HC TIB INS TRL
  • INTX INSRT TRL
  • INTX TIB TRIAL
  • INX HC TIB INS TRL
  • IX FEM DST BLK TRL
  • IX HC TIB INS TRI
  • IX MENISCAL TRL
  • JADE TRIAL
  • K+ RS TRIALS
  • KMS TRIAL
  • KMTC TRIAL
  • KMX+ TRIL SPCR
  • KRH ALL POLY FIN BROACH
  • LEFT HALF MONOGRAM KNEE DURACON FLAT TIBIAL WEDGE TRIAL
  • MDM MONOPOLAR TRIAL INSERT
  • MET ENCA TIB TRLINSERT
  • MONOGRAM KNEE DURACON FULL FLAT TIBIAL WEDGE TRIAL
  • NECK EXTENSION
  • NEUTRAL TRIAL INSERT
  • OFFSET HUMERAL BEAR TRIAL
  • OMNIFIT STEM TRIAL HEAD
  • PATELLA TRIAL
  • PCA HOOD TRIAL INSERT
  • PCA MTK/DURA REV TR INS
  • PCA NEUT TRIAL INSERT
  • PCA NEUT/DURA REV TR INS
  • PCA TIBIAL TRIAL
  • PCA TRIAL HEAD
  • PCA TRIAL HEAD
  • RADIAL HEAD PROSTHESIS, TRIAL COMPONENT
  • RADIOPAQUE FEMORAL TRIAL HEAD
  • RIGHT HALF MONOGRAM KNEE DURACON FLAT TIBIAL WEDGE TRIAL
  • SCORPIO FEMORAL TRIAL
  • SCORPIO TCG TIBIAL TRIAL
  • SCORPIO TIBIAL TRIAL
  • SCORPIO TRIAL
  • SPECIALITY V40 HEAD TRIAL
  • SPECIALTY DURACON INSET PATELLA TRIAL
  • SPECIALTY PATELLA TRIAL
  • SPECIALTY V40 HEADS TAPER LOCK SIZE OFFSET
  • SPECIALTY V40 SKIRTED HEADS TAPER LOCK SIZE OFFSET
  • SYSTEM 7 - RECIPROCATING SAW
  • THREADED STEM TRIAL HEAD
  • TIB INSERT TRIAL - DURATION TOT KNEE
  • TIBIAL TRIAL
  • TRIAL FEMORAL HEAD
  • TRIAL HEAD
  • TRIAL INSERT
  • TRIAL PEDIATRIC ALL POLY TIBIA
  • TRIAL TIBIAL PLUG
  • TRIAL TRIDENT
  • TRIAL UNIVERSAL HEAD
  • TRIAL, PLUG
  • TRIDENT ALL POLY CONSTRAINED LINER
  • TRIDENT ALL-POLY CUP TRIAL
  • TRIDENT INSERT TRIALS ASSEMBLY
  • TRIDENT INSERT TRL
  • TRL UNIVRSL HD
  • UNI INSERT TRIAL TIBIAL
  • UNITRAX TRIAL HEAD
  • V40 SLEEVE TRIAL FOR ADM/MDM

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