510(k) K926465

FEMORAL INTRAMEDULLARY RODS by Applied Osteo Systems, Inc. — Product Code JDS

K926465 is an FDA 510(k) premarket notification submitted by Applied Osteo Systems, Inc. for the device "FEMORAL INTRAMEDULLARY RODS". The FDA issued a decision of Substantially Equivalent on August 25, 1993. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Applied Osteo Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1993
Date Received
December 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nail, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type