Product code QJD

Device name

Absorbable Metallic Bone Fixation Fastener

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3041

Review panel

OR

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

An absorbable metallic bone fixation fastener is an implant, such as a bone screw, pin, or Kirschner wire, composed of one or more absorbable metal or metal alloys and intended to provide rigid bone fixation suitable for osteosynthesis. The device is designed to fully absorb after steosynthesis is achieved.

Source

FDA openFDA device classification dataset