Appliances And Accessories, Fixation, Bone, Absorbable Single/multiple Component

Device Code: 4628

Product Code(s): MRY

Device Classification Information

• Device Type ID: 4628
• Device Name: Appliances And Accessories, Fixation, Bone, Absorbable Single/multiple Component
• Regulation Description: Smooth Or Threaded Metallic Bone Fixation Fastener.
• 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: 888.3040 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MRY
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 8-423 ASTM F2565-13
  Standard Guide For Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms For Surgical Implant Applications
• 8-424 ASTM F2695-12
  Standard Specification For Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) And Fabricated Forms For Surgical Implant Applications

Total Product Life Cycle

• Device Type ID: 4628
• Device: Appliances And Accessories, Fixation, Bone, Absorbable Single/multiple Component
• Product Code: MRY
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Smooth Or Threaded Metallic Bone Fixation Fastener.
• CFR Regulation Number: 888.3040 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:53:03