Countersink

Device Code: 4501

Product Code(s): HWW

Device Classification Information

• Device Type ID: 4501
• Device Name: Countersink
• 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: HWW
• 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: 4501
• Device: Countersink
• Product Code: HWW
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Orthopedic Manual Surgical Instrument.
• CFR Regulation Number: 888.4540 [🔎]

Device Problems
Material Fragmentation	3
Fracture	3
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	7

TPLC Last Update: 2019-04-02 20:50:36