Data / Medical devices / Orthopedic Augmented Reality / United States
FDA-registered makers of Orthopedic Augmented Reality in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Orthopedic Augmented Reality (product code SBF). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Orthopedic Augmented Reality
- Product code
- SBF
- Country
- United States
Makers of Orthopedic Augmented Reality in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Augmedics Ltd. | Elgin, IL, United States | Manufacturer | 7 | July 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| Onpoint Surgical | Concord, MA, United States | Manufacturer | 2 | August 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Surgical Theater, Inc. | Beachwood, OH, United States | Complaint file establishment, Manufacturer | 2 | September 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 1 | July 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Insight Medical Systems, Inc | Austin, TX, United States | Specification developer | 1 | January 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Polarisar Inc | Richardson, TX, United States | Complaint file establishment, Specification developer | 1 | November 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novus Manufacturing Solutions | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Planning Associates | Boston, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| proNet, A Division Desco Industries Inc. | Anaheim, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.