Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

QNI · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3044

Classification

FDA Product Code: QNI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3044
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 3

Source

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