Manual Instruments Designed For Use With Total Disc Replacement Devices
Medical specialty
Orthopedic
Device class
2
Regulation number
888.4515
Review panel
OR
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.