Data / Medical devices / United States / Curvafix, Inc.
Curvafix, Inc.: FDA-registered device maker in Kirkland, WA, United States, 1 510(k) clearance
Curvafix, Inc. is registered with the FDA (registration 3016537375) in Kirkland, WA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016537375
- Address
- 10220 Points Dr NE Suite 300, Kirkland, WA, United States, 98033
- Owner or operator
- CurvaFix, Inc. (10080748)
- Roles
- Manufacturer
- First device listed
- September 22, 2023
- Registered through
- 2026
- Brand names listed
- CurvaFix Extraction Set, CurvaFix Flexible Disposable Redirect Shaft, CurvaFix Low Profile System, CurvaFix Redirect System Instrument Set, CurvaFix Removal Tool Set, CurvaFix Standard Disposable Redirect Shaft
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 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 29, 2025 | K252019 | CurvaFix Low Profile System | HWC | Substantially Equivalent | Curvafix, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Screw, Fixation, Bone
- All makers of Washer, Bolt Nut
Updated August 29, 2025. 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.