510(k) K984251

XIA SPINE SYSTEM by Howmedica, Inc. — Product Code KWQ

K984251 is an FDA 510(k) premarket notification submitted by Howmedica, Inc. for the device "XIA SPINE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 24, 1999. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Howmedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1999
Date Received
November 27, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type