510(k) K241592

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

K241592 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 August 31, 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
August 31, 2024
Date Received
June 3, 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