System, External Fixator (with Metallic Invasive Components)

Device Code: 4637

Product Code(s): NDK

Device Classification Information

• Device Type ID: 4637
• Device Name: System, External Fixator (with Metallic Invasive Components)
• 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 One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
• Submission Type: 510(k)
• CFR Regulation Number: 888.3040 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NDK
• 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
• 11-197 ASTM F983-86 (Reapproved 2018)
  Standard Practice For Permanent Marking Of Orthopaedic Implant Components
• 11-199 ASTM F565-04 (Reapproved 2018)
  Standard Practice For Care And Handling Of Orthopedic Implants And Instruments

Total Product Life Cycle

• Device Type ID: 4637
• Device: System, External Fixator (with Metallic Invasive Components)
• Product Code: NDK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Smooth Or Threaded Metallic Bone Fixation Fastener.
• CFR Regulation Number: 888.3040 [🔎]

Premarket Reviews
Manufacturer	Decision
3D MEDICAL CONCEPTS, LLC
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 20:53:15