510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QNIClass II

Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

21 CFR 888.3044 / Orthopedic
FDA source (opens on fda.gov)

QNI is the FDA product code for Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair, a class II device type, regulated under 21 CFR 888.3044. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
QNI
Device name
Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
FDA 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.
Regulation
21 CFR 888.3044
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
2

Clearances, product code QNI

By decision year
3 clearances under product code QNI with a decision year between 2020 and 2026, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QNI by decision year
YearClearances
20201
20251
20261

Applicants with the most clearances

Product code QNI
Applicants holding the most 510(k) clearances under product code QNI
ApplicantClearances
Miach Orthopaedics3

Companies listing this code with FDA

Companies whose registered establishments list this code