Scissors, Orthopedic, Surgical

Device Code: 4460

Product Code(s): HRR

Device Classification Information

Device Type ID4460
Device NameScissors, Orthopedic, Surgical
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 CodeHRR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4460
DeviceScissors, Orthopedic, Surgical
Product CodeHRR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOrthopedic Manual Surgical Instrument.
CFR Regulation Number888.4540 [🔎]
Device Problems
Fracture
3
Material Fragmentation
1
Off-Label Use
1
Manufacturing, Packaging Or Shipping Problem
1
Defective Device
1
Packaging Problem
1
Total Device Problems 8
TPLC Last Update: 2019-04-02 20:49:36

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