Instruments Designed For Press-Fit Osteochondral Implants
Medical specialty
Orthopedic
Device class
2
Regulation number
888.4505
Review panel
OR
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants.