510(k) K231453

SnapHammer Hammertoe Correction System by Nvision Biomedical Technologies, Inc. — Product Code HWC

K231453 is an FDA 510(k) premarket notification submitted by Nvision Biomedical Technologies, Inc. for the device "SnapHammer Hammertoe Correction System". The FDA issued a decision of Substantially Equivalent on February 16, 2024. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Nvision Biomedical Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2024
Date Received
May 18, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type