510(k) K202152
K202152 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "NextAR TKA Platform". The FDA issued a decision of Substantially Equivalent on Oct 27, 2020. The device falls under product code SBF (Orthopedic Augmented Reality), a Class II device regulated under 21 CFR 882.4560. Medacta International S.A. has 207 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 27, 2020
- Date Received
- Aug 3, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthopedic Augmented Reality
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- OR
- Submission Type
- 510(k)
An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as augmented reality stereoscopic images to intraoperatively augment the users field of view.