• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device kit, laparoscopic, bone anchor, urethropexy
Regulation Description Smooth or threaded metallic bone fixation fastener.
Definition Laparoscopic bone anchor urethropexy instrument kit.
Physical State Laparoscopic Bone Anchor Urethropexy Instrument Kit
Technical Method Laparoscopic Bone Anchor Urethropexy Instrument Kit
Target Area Laparoscopic Bone Anchor Urethropexy Instrument Kit
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeNWN
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)
Regulation Number 888.3040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Convenience Kits Interim Regulatory Guidance
Third Party Review
Accredited Persons

-
-