510(k) K082187

BIOMET ANTERIOR LUMBAR PLATE by Ebi, L.P. — Product Code KWQ

K082187 is an FDA 510(k) premarket notification submitted by Ebi, L.P. for the device "BIOMET ANTERIOR LUMBAR PLATE". The FDA issued a decision of Substantially Equivalent on November 13, 2008. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Ebi, L.P. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2008
Date Received
August 4, 2008
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