510(k) K200113
K200113 is an FDA 510(k) premarket notification submitted by Waldemar Link GmbH & Co. KG for the device "LINK TrabecuLink Tibial Cones". The FDA issued a decision of Substantially Equivalent on Mar 18, 2020. 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. Waldemar Link GmbH & Co. KG has 42 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 18, 2020
- Date Received
- Jan 17, 2020
- 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)