Product Classification

• 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 Code: NWN
• 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

• ASTM F 983-86 (Reapproved 2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care and Handling of Orthopedic Implants and Instruments

Guidance Document

• Convenience Kits Interim Regulatory Guidance

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• tuv sud america inc.
• underwriters laboratories, inc.