Medical device licence · 99440 · Class 3
MAKO SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 26, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99440
- Licence holder
- Mako Surgical Corp.Weston, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 26, 2017
- Devices covered
- 58
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 3.1 MAKO ROBOTIC ARM
- ANATO NEUTRAL TRIAL NECK
- ARRAY STABILIZER
- BLUNT INTRODUCER
- BURR GUARD ASSEMBLY
- CREST DRILL GUIDE
- DOUBLE BARREL DRILL GUIDE
- HYBRID TIP POINTER
- IRRIGATION CLIP
- MAKO 4 ROBOTIC ARM
- MAKO BALL BURR
- MAKO BLADE
- MAKO CAMERA STAND ASSEMBLY
- MAKO GUIDANCE MODULE
- MAKO GUIDANCE MODULE/CAMERA STAND ASSEMBLY
- MAKO PKA 3.0.2 + THA 4.0 + TKA 1.0.1 SOFTWARE DISC
- MAKO ROBOTIC ARM
- MAKO SAGITTAL BLADE
- MICS 3 HANDPIECE
- MICS 3 SAGITTAL SAW ATTACHMENT
- MICS HANDPIECE
- MICS IRRIGATION CLIP
- PKA 2.5.6.4 + THA 3.1.1.1 UPGRADE DISC
- PKA 2.5.6.4 UPGRADE DISK
- PKA 2.5.6.4 UPGRADE KIT
- PKA 3.0 + THA 3.1.2 + TKA 1.0 + PKA 2.5.6.4 DISC
- PKA 3.0.2/THA 3.1.3 UPGRADE DISC
- PKA 3.0.2/THA 3.1.3/TKA 1.0.1 UPGRADE DISC
- REAMER ATTACHMENT
- RESTORIS RIO REAMER HANDLE
- RIGHT ANGLE SAW ATTACHMENT
- RIO SYSTEM IRRIGATION TUBE
- ROTARY ATTACHMENT
- SAGITTAL SAW ATTACHMENT
- SILICONE RETRACTOR CORD
- THA 3.1.1.1 + PKA 2.5.6.4 UPGRADE KIT
- THA 5.0, MGO 1.6 LAPTOP UPGRADE DISK
- THA 5.0, TKA 2.1, PKA 3.1 INSTALL DISK
- TKA 1.0 + PKA 2.5.6.3 + THA 3.1.1.1 DISC
- TKA 1.0 + PKA 2.5.6.3 + THA 3.1.2 DISC
- TKA 1.0 + PKA 2.5.6.3 + THA 3.1.2 KIT UPGRADE KIT
- TKA 1.0 + PKA 2.5.6.4 + THA 3.1.1.1 DISC
- TKA 1.0 + PKA 2.5.6.4 + THA 3.1.2 DISC
- TKA 1.0 + PKA 2.5.6.4 + THA 3.1.2 KIT UPGRADE KIT
- TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2
- TKA 1.0.3 + THA 3.1.4 + PKA 3.0.4 + MGO 1.1.9.1
- TKA 1.0.3 + THA 4.0.2 + PKA 3.0.4 + MGO 1.2.1.1
- TKA 1.0.3 + THA 4.1.1 + PKA 3.0.4 + MGO 1.2.2.1
- TKA 2.0 + THA 10.1 + PKA 3.0.2 + MGO 1.2.2
- TKA 2.0 + TKA1.0.1+ THA 4.0.0.1 + PKA 3.0.2 + MGO 1.2.2
- TKA 2.0 + TKA1.0.1+ THA 4.1. + PKA 3.0.2 + MGO 1.2.2
- TKA 2.0 + TKA1.0.3+ THA 4.0.2 + PKA 3.0.4 + MGO 1.2.2.1
- TKA 2.0 + TKA1.0.3+ THA 4.1.1 + PKA 3.0.4 + MGO 1.2.2.1
- TKA 2.1, THA 4.2, PKA 3.1 INSTALL DISK
- TKA 3.0 LAPTOP UPGRADE DISK
- TKA 3.0, THA 4.2, PKA 3.1 INSTALL DISK
- TKA 3.0, THA 5.0, PKA 3.1 INSTALL DISK
- VARIABLE ANGLE FIXATION SCREW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.