510(k) K102927
K102927 is an FDA 510(k) premarket notification submitted by Consensus Orthopedics, Inc. for the device "CONSENSUS KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 26, 2011. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Consensus Orthopedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 2011
- Date Received
- October 4, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3565
- Review Panel
- OR
- Submission Type