510(k) K984364

SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 by Syntec Scientific Corp. — Product Code KTT

K984364 is an FDA 510(k) premarket notification submitted by Syntec Scientific Corp. for the device "SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820". The FDA issued a decision of Substantially Equivalent on Mar 2, 1999. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Syntec Scientific Corp. has 12 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 2, 1999
Date Received
Dec 7, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type
510(k)

Source: FDA 510(k) database entry for K984364. Report a data issue: hello@regdatalab.com.