510(k) K182171

SMV Scientific K-Wire and Pins by Summit Medventures — Product Code JDW

K182171 is an FDA 510(k) premarket notification submitted by Summit Medventures for the device "SMV Scientific K-Wire and Pins". The FDA issued a decision of Substantially Equivalent on October 25, 2018. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Summit Medventures has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2018
Date Received
August 10, 2018
Clearance Type
Traditional
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