510(k) K073120
K073120 is an FDA 510(k) premarket notification submitted by Accelerated Innovation, LLC for the device "ACCIN PATELLOFEMORAL SYSTEM". The FDA issued a decision of Substantially Equivalent on February 29, 2008. The device falls under product code KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3540. Accelerated Innovation, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 29, 2008
- Date Received
- November 5, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3540
- Review Panel
- OR
- Submission Type