510(k) K893377

RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS by Richards Medical Co., Inc. — Product Code HSB

K893377 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS". The FDA issued a decision of Substantially Equivalent on November 16, 1989. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1989
Date Received
May 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type