Rongeur

Device Code: 4485

Product Code(s): HTX

Device Classification Information

Device Type ID4485
Device NameRongeur
Regulation DescriptionOrthopedic Manual Surgical Instrument.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type510(K) Exempt
CFR Regulation Number888.4540 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHTX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4485
DeviceRongeur
Product CodeHTX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOrthopedic Manual Surgical Instrument.
CFR Regulation Number888.4540 [🔎]
Device Problems
Break
49
Fracture
12
Material Fragmentation
7
Material Deformation
3
Insufficient Information
3
Missing Value Reason
3
Bent
3
Adverse Event Without Identified Device Or Use Problem
2
Component Missing
2
Appropriate Term/Code Not Available
2
Mechanical Problem
2
Detachment Of Device Or Device Component
1
Loose Or Intermittent Connection
1
Detachment Of Device Component
1
Material Torqued
1
Failure To Cut
1
Device Dislodged Or Dislocated
1
Delivered As Unsterile Product
1
Contamination / Decontamination Problem
1
Cutter
1
Device Operates Differently Than Expected
1
Material Twisted / Bent
1
Corroded
1
Material Discolored
1
Device Inoperable
1
Material Integrity Problem
1
Device Fell
1
Total Device Problems 104
Recalls
Manufacturer Recall Class Date Posted
1
Exactech, Inc.
II Jul-03-2017
TPLC Last Update: 2019-04-02 20:50:17

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