510(k) K843449

AUTODYNAMIC COMPRESSION HIP SCREW-PLATE by Mecron Medical Products, Inc. — Product Code KTT

K843449 is an FDA 510(k) premarket notification submitted by Mecron Medical Products, Inc. for the device "AUTODYNAMIC COMPRESSION HIP SCREW-PLATE". The FDA issued a decision of Substantially Equivalent on October 22, 1984. 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. Mecron Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1984
Date Received
September 5, 1984
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