510(k) K895241

INTRAMEDULLARY HIP SCREW by Richards Medical Co., Inc. — Product Code KTT

K895241 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "INTRAMEDULLARY HIP SCREW". The FDA issued a decision of Substantially Equivalent on January 4, 1990. 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. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1990
Date Received
August 21, 1989
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