Knee+
510(k) K202750
Knee+ is a medical device (FDA Class II; FDA product code SBF, Orthopedic Augmented Reality) made by Pixee Medical, cleared under FDA 510(k) K202750 on 21 Apr 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202750 | Date21 Apr 2021 | StatusActive |
Official records
- FDA 510(k) database K202750
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- SBF
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code SBF (Orthopedic Augmented Reality).
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- NextAR Hip Platform by Medacta International S.A.
- NextAR™ Spine Platform by Medacta International S.A.
- OnPoint Augmented Reality Spine System by OnPoint Surgical, Inc.
- ARVIS ® IN-28000 by KICO KNEE INNOVATION COMPANY PTY LIMITED