Laparoscopic Bone Anchor Urethropexy Instrument Kit

Device Code: 4651

Product Code(s): NWN

Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.

Device Classification Information

• Device Type ID: 4651
• Device Name: Laparoscopic Bone Anchor Urethropexy Instrument Kit
• Physical State: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.
• Technical Method: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.
• Target Area: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.
• 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: Enforcement Discretion
• CFR Regulation Number: 888.3040 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NWN
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

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: 4651
• Device: Laparoscopic Bone Anchor Urethropexy Instrument Kit
• Product Code: NWN
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Smooth Or Threaded Metallic Bone Fixation Fastener.
• CFR Regulation Number: 888.3040 [🔎]

TPLC Last Update: 2019-04-02 20:53:27