Knife, Orthopedic

Device Code: 4482

Product Code(s): HTS

Device Classification Information

Device Type ID	4482
Device Name	Knife, Orthopedic
Regulation Description	Orthopedic Manual Surgical Instrument.
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) Exempt
CFR Regulation Number	888.4540 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	HTS
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

8-344 ISO 7153-1 Second Edition 1991-04-01 Surgical Instruments -- Metallic Materials -- Part 1: Stainless Steel [Including: Amendment 1 (1999)] 8-478 ASTM F1089-18 Standard Test Method For Corrosion Of Surgical Instruments 11-83 ISO 13402 First Edition 1995-08-01 Surgical And Dental Hand Instruments -- Determination Of Resistance Against Autoclaving, Corrosion And Thermal Exposure 11-199 ASTM F565-04 (Reapproved 2018) Standard Practice For Care And Handling Of Orthopedic Implants And Instruments 11-226 ASTM F1089-10 Standard Test Method For Corrosion Of Surgical Instruments

Total Product Life Cycle

Device Type ID	4482
Device	Knife, Orthopedic
Product Code	HTS
FDA Device Classification	Class 1 Medical Device
Regulation Description	Orthopedic Manual Surgical Instrument.
CFR Regulation Number	888.4540 [🔎]

Device Problems
Break	2
Knife	1
Fracture	1
Total Device Problems	4

TPLC Last Update: 2019-04-02 20:50:12