510(k) K200933

Syntec Non-Sterile Steinmann Pins System by Syntec Scientific Corporation — Product Code JDW

K200933 is an FDA 510(k) premarket notification submitted by Syntec Scientific Corporation for the device "Syntec Non-Sterile Steinmann Pins System". The FDA issued a decision of Substantially Equivalent on May 5, 2020. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Syntec Scientific Corporation has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2020
Date Received
April 7, 2020
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