Cleared Special

K210754 - Cannulated Fasteners and Nuts
(FDA 510(k) Clearance)

K210754 · OsteoCentric Technologies · Orthopedic

Apr 2021

Decision

30d

Days

Class 2

Risk

K210754 is an FDA 510(k) clearance for the Cannulated Fasteners and Nuts, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by OsteoCentric Technologies (Logan, US). The FDA issued a Cleared decision on April 14, 2021, 30 days after receiving the submission on March 15, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K210754 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2021
Decision Date	April 14, 2021
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF