Data / Medical devices / United States / Onpoint Surgical
Onpoint Surgical: FDA-registered device maker in Concord, MA, United States, 2 510(k) clearances
Onpoint Surgical is registered with the FDA (registration 3016534677) in Concord, MA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016534677
- Address
- 555 Virginia Rd Suite 103, Concord, MA, United States, 01742
- Owner or operator
- OnPoint Surgical (10090623)
- Roles
- Manufacturer
- First device listed
- April 20, 2024
- Registered through
- 2026
- Brand names listed
- OnPoint Augmented Reality Spine System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Augmented Reality | SBF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 19, 2024 | K241870 | OnPoint Augmented Reality Spine System | SBF | Substantially Equivalent | Onpoint Surgical, Inc. | accessdata.fda.gov |
| September 8, 2023 | K231284 | OnPoint Augmented Reality Spine System | SBF | Substantially Equivalent | Onpoint Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 19, 2024. 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.