510(k) K210784

Extended HA Half Pins by Smith & Nephew, Inc. — Product Code JDW

K210784 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "Extended HA Half Pins". The FDA issued a decision of Substantially Equivalent on April 2, 2021. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2021
Date Received
March 16, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type