510(k) K242554

Arthrex VAL and VAL KreuLock™ Compression Screw System by Arthrex, Inc. — Product Code HRS

K242554 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex VAL and VAL KreuLock™ Compression Screw System". The FDA issued a decision of Substantially Equivalent on October 21, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2024
Date Received
August 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type