Transtibial Anterior Cruciate Ligament Kit
The Transtibial Anterior Cruciate Ligament Kit is a convenience kit containing instruments and supplies used in transtibial ACL reconstruction surgery to repair or replace the anterior cruciate ligament of the knee. It is classified as FDA Class 2 under 21 CFR 888.3040 in the Orthopedic specialty. Per the FDA's 1997 Convenience Kits Interim Regulatory Guidance, this type of kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all applicable criteria. Product code PPQ; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PPQ
- Device Class
- FDA class 2
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 7
Device Characteristics
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.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.