VeriFixx Small Bone Implant
FDA 510(k) K202777 · Armis Biopharma, Inc.
510(k) numberK202777
Submission
- Device name
- VeriFixx Small Bone Implant
- Applicant
- Armis Biopharma, Inc.
Fort Collins, CO, US - Received
- September 22, 2020
- Decision date
- November 17, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
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| K220759 | Armis VeriCyn Wound WashFQH · Traditional | 05/25/2023SE |
Questions and answers
When was VeriFixx Small Bone Implant cleared by the FDA?
VeriFixx Small Bone Implant (K202777) received a 510(k) decision of Substantially Equivalent on November 17, 2020, 56 days after the submission was received.
What is the product code of K202777?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.