NextAR Shoulder Platform
510(k) K251737
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251737 | Date4 Sep 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- NextAR(TM) Shoulder Platform
- 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
Overview
AI-generated summary, 19 Sep 2026
The NextAR Shoulder Platform is an Orthopedic Augmented Reality system designed to assist in surgical procedures for shoulder interventions. It integrates augmented reality technology with patient-specific data to enhance precision during orthopedic surgeries, providing real-time guidance and visualization for implant placement and anatomical alignment.
This system is supplied as a modular platform, including augmented reality glasses, a software application, and a single-use tracking system. It is intended for use in sterile surgical environments and is classified as a Class II medical device under FDA regulations. The platform requires no sterilization between uses and is authorized for use in the United States under FDA 510(k) clearance (K251737).