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 Type ID | 4645 |
Device Name | Anchor, Suture, Bone Fixation, Metallic |
Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
Regulation Medical Specialty | Orthopedic |
Review Panel | Orthopedic |
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 Type | 510(k) |
CFR Regulation Number | 888.3030 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NOV |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
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Device Type ID | 4645 |
Device | Anchor, Suture, Bone Fixation, Metallic |
Product Code | NOV |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
CFR Regulation Number | 888.3030 [🔎] |
Device Problems | |
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Insufficient Information | 2 |
Total Device Problems | 2 |
Recalls | |||
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Manufacturer | Recall Class | Date Posted | |
1 | Integra LifeSciences Corp. | II | Sep-07-2016 |