Product code PLF

Device name

Bone Wedge

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3030

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.

Source

FDA openFDA device classification dataset