Anchor, Suture, Bone Fixation, Metallic

Device Code: 4645

Product Code(s): NOV

Definition: This Device Is Indicated For Attaching Suture Into Bone For Suspension Of The Nasal Valve And For Attaching Suture Into Bone At The Lower Orbital Rim.

Device Classification Information

Device Type ID4645
Device NameAnchor, Suture, Bone Fixation, Metallic
Regulation DescriptionSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Submission Type510(k)
CFR Regulation Number888.3030 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNOV
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4645
DeviceAnchor, Suture, Bone Fixation, Metallic
Product CodeNOV
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.
CFR Regulation Number888.3030 [🔎]
Device Problems
Insufficient Information
2
Total Device Problems 2
Recalls
Manufacturer Recall Class Date Posted
1
Integra LifeSciences Corp.
II Sep-07-2016
TPLC Last Update: 2019-04-02 20:53:22

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