510(k) K182346
K182346 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws". The FDA issued a decision of Substantially Equivalent on Nov 26, 2018. 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. Exactech, Inc. has 185 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 26, 2018
- Date Received
- Aug 28, 2018
- 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
- 510(k)