Data / Medical devices / United States / Accufix Surgical, Inc.
Accufix Surgical, Inc.: FDA-registered device maker in Laramie, WY, United States, 2 510(k) clearances
Accufix Surgical, Inc. is registered with the FDA (registration 3020650900) in Laramie, WY, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 29, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020650900
- Address
- 3821 Beech St, Laramie, WY, United States, 82070
- Owner or operator
- Accufix Surgical, Inc. (10082818)
- Roles
- Specification developer
- First device listed
- October 6, 2021
- Registered through
- 2026
- Brand names listed
- Accu-Joint Hemi Implant, Accu-Joint Hemi Implant Instrument Kit, Accu-joint Hemi Implant Single Sterile
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | 2 | Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | 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 |
|---|---|---|---|---|---|---|
| February 29, 2024 | K240268 | Accu-Joint Hemi Implant | KWD | Substantially Equivalent | Accufix Surgical, Inc. | accessdata.fda.gov |
| December 8, 2020 | K200951 | Accu-Joint Hemi Implant | KWD | Substantially Equivalent | Accufix Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Guide, Surgical, Instrument
- All makers of Tap, Bone
- All makers of Reamer
- All makers of Prosthesis, Toe, Hemi-, Phalangeal
- All makers of Tray, Surgical, Instrument
- All makers of Bit, Drill
Updated February 29, 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.