Data / Medical devices / United States / Orthocircle
Orthocircle: FDA-registered device maker in Savannah, GA, United States, 2 510(k) clearances
Orthocircle is registered with the FDA (registration 3009132077) in Savannah, GA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 10, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009132077
- Address
- 6602 Abercorn St Ste 200, Savannah, GA, United States, 31405
- Owner or operator
- OrthoCircle North America, LLC (10036579)
- Roles
- Specification developer
- First device listed
- November 14, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 10, 2023 | K222799 | Haymaker® Screw System | HWC | Substantially Equivalent | Orthocircle Spine D.B.A. OC Medical Devices | accessdata.fda.gov |
| October 14, 2022 | K221172 | FOCUS Interbody System | MAX | Substantially Equivalent | Oc Medical Devices | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Screw, Fixation, Bone
Updated January 10, 2023. 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.