510(k) K173445
K173445 is an FDA 510(k) premarket notification submitted by Materialise NV for the device "Materialise TKA Guide System". The FDA issued a decision of Substantially Equivalent on Feb 2, 2018. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Materialise NV has 60 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 2, 2018
- Date Received
- Nov 6, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3560
- Review Panel
- OR
- Submission Type
- 510(k)