510(k) K961522

KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN by Synvasive Technology, Inc. — Product Code HTY

K961522 is an FDA 510(k) premarket notification submitted by Synvasive Technology, Inc. for the device "KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN". The FDA issued a decision of Substantially Equivalent on September 23, 1996. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Synvasive Technology, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1996
Date Received
April 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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