Device, Fixation, Proximal Femoral, Implant

Device Code: 4528

Product Code(s): JDO

Device Type ID	4528
Device Name	Device, Fixation, Proximal Femoral, Implant
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 Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type	510(k)
CFR Regulation Number	888.3030 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	JDO
GMP Exempt	No
Summary MR	Eligible
Implanted Device	Yes
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	4528
Device	Device, Fixation, Proximal Femoral, Implant
Product Code	JDO
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
Insufficient Information	33
Appropriate Term/Code Not Available	20
Fracture	11
Break	8
Adverse Event Without Identified Device Or Use Problem	7
Difficult To Insert	4
Difficult To Position	2
Failure To Align	1
Mechanical Problem	1
Difficult To Advance	1
Material Deformation	1
Unintended Movement	1
Device Issue	1
Separation Failure	1
Device Packaging Compromised	1
Mechanical Jam	1
Delivered As Unsterile Product	1
Use Of Device Problem	1
Migration Or Expulsion Of Device	1
Device Operates Differently Than Expected	1
Bent	1
Corroded	1
Tear, Rip Or Hole In Device Packaging	1
Total Device Problems	101

TPLC Last Update: 2019-04-02 20:51:09