510(k) K210754

Cannulated Fasteners and Nuts by OsteoCentric Technologies — Product Code HWC

K210754 is an FDA 510(k) premarket notification submitted by OsteoCentric Technologies for the device "Cannulated Fasteners and Nuts". The FDA issued a decision of Substantially Equivalent on April 14, 2021. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. OsteoCentric Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2021
Date Received
March 15, 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