510(k) K210980

Smith & Nephew Intramedullary Nail Systems by Smith & Nephew, Inc. — Product Code HSB

K210980 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "Smith & Nephew Intramedullary Nail Systems". The FDA issued a decision of Substantially Equivalent on Nov 14, 2022. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 14, 2022
Date Received
Apr 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type
510(k)