510(k) K202777
K202777 is an FDA 510(k) premarket notification submitted by Armis Biopharma, Inc. for the device "VeriFixx Small Bone Implant". The FDA issued a decision of Substantially Equivalent on November 17, 2020. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Armis Biopharma, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 2020
- Date Received
- September 22, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type