FDA product code QNI

Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

Orthopedic·Class 2·21 CFR 888.3044·Implantable
US regulatory classifications
US Product Code (FDA)
QNI
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.3044
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.