510(k) K984305

ZETA MULTIZONE LOCKING NAIL SYSTEM by Howmedica, Inc. — Product Code HSB

K984305 is an FDA 510(k) premarket notification submitted by Howmedica, Inc. for the device "ZETA MULTIZONE LOCKING NAIL SYSTEM". The FDA issued a decision of Substantially Equivalent on February 1, 1999. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Howmedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1999
Date Received
December 2, 1998
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