Product code HSH

Device name

Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3590

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset