510(k) K240530

DynaNail Mini Tapered Hybrid by MedShape, Inc. — Product Code HWC

K240530 is an FDA 510(k) premarket notification submitted by MedShape, Inc. for the device "DynaNail Mini Tapered Hybrid". The FDA issued a decision of Substantially Equivalent on March 21, 2024. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. MedShape, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2024
Date Received
February 23, 2024
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