510(k) K213421

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

K213421 is an FDA 510(k) premarket notification submitted by Nvision Biomedical Technologies, Inc. for the device "Vector® Hammertoe Correction System". The FDA issued a decision of Substantially Equivalent on November 19, 2021. 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
November 19, 2021
Date Received
October 20, 2021
Clearance Type
Special
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