Absorbable Metallic Bone Fixation Fastener

QJD · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3041

Classification

FDA Product Code: QJD
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3041
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: Y
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown