Instrument, Cutting, Orthopedic

Device Code: 5681

Product Code(s): HTZ

Device Type ID	5681
Device Name	Instrument, Cutting, Orthopedic
Regulation Description	Manual Surgical Instrument For General Use.
Regulation Medical Specialty	General & Plastic Surgery
Review Panel	General & Plastic Surgery
Premarket Review	Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type	510(K) Exempt
CFR Regulation Number	878.4800 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	HTZ
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	5681
Device	Instrument, Cutting, Orthopedic
Product Code	HTZ
FDA Device Classification	Class 1 Medical Device
Regulation Description	Manual Surgical Instrument For General Use.
CFR Regulation Number	878.4800 [🔎]

Device Problems
Break	65
Device-Device Incompatibility	11
Appropriate Term/Code Not Available	10
Activation, Positioning Or Separation Problem	8
Mechanical Problem	8
Material Deformation	6
Material Fragmentation	5
Mechanical Jam	5
Difficult To Remove	5
Material Twisted / Bent	5
Detachment Of Device Or Device Component	4
Cut In Material	3
Loose Or Intermittent Connection	3
Material Separation	2
Device Issue	2
Physical Resistance / Sticking	2
Device Operates Differently Than Expected	2
Device Operational Issue	2
Component Missing	2
Connection Problem	2
Adverse Event Without Identified Device Or Use Problem	2
Contamination / Decontamination Problem	1
Disassembly	1
Bent	1
Fracture	1
Device Contamination With Chemical Or Other Material	1
Sticking	1
Dull, Blunt	1
Entrapment Of Device	1
Difficult To Insert	1
Naturally Worn	1
Total Device Problems	164

TPLC Last Update: 2019-04-02 21:10:44