510(k) K240815

Arthrex Cannulated Screw System by Arthrex, Inc. — Product Code HWC

K240815 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Cannulated Screw System". The FDA issued a decision of Substantially Equivalent on June 13, 2024. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Arthrex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2024
Date Received
March 25, 2024
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