SpineAR SNAP
510(k) K213034
SpineAR SNAP is a medical device (FDA Class II; FDA product code SBF, Orthopedic Augmented Reality) made by Surgical Theater, Inc., cleared under FDA 510(k) K213034 on 29 Sep 2022, 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 | NumberK213034 | Date29 Sep 2022 | StatusActive |
Official records
- FDA 510(k) database K213034
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- Withdrawn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
Devices cleared under K213034
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| SpineAR SNAP | SpineAR | 00860003884126 | — | On the market |
Similar devices
Other devices filed under FDA product code SBF (Orthopedic Augmented Reality).
- NextAR TKA Platform 02.23.10.0013 by Medacta International SA
- NextAR Spine Platform 03.57.10.0044 by Medacta International SA
- NextAR™ TKA Platform My Knee PPS by Medacta International S.A.
- OptiVu™ Shoulder by Mr Surgical Solutions, LLC
- OnPoint Augmented Reality Spine System by OnPoint Surgical, Inc.
- ARVIS ® IN-23600 by KICO KNEE INNOVATION COMPANY PTY LIMITED
- Arvis Shoulder by Kico Knee Innovation Company Pty Ltd
- ARVIS ® IN-26100 by KICO KNEE INNOVATION COMPANY PTY LIMITED
- Knee+ by PIXEE MEDICAL
- Mixed Reality Spine Navigation by Brainlab AG