510(k) K213781
K213781 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP". The FDA issued a decision of Substantially Equivalent on Jan 18, 2022. 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. Depuy Ireland UC has 49 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 18, 2022
- Date Received
- Dec 3, 2021
- Clearance Type
- Special
- 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
- 510(k)