510(k) K960023

KIRSHNER WIRES (K-WIRE) & STEINMANN PINS by Promex, Inc. — Product Code JDW

K960023 is an FDA 510(k) premarket notification submitted by Promex, Inc. for the device "KIRSHNER WIRES (K-WIRE) & STEINMANN PINS". The FDA issued a decision of Substantially Equivalent on March 18, 1996. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Promex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1996
Date Received
January 2, 1996
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