510(k) K955730

EBI ANTERIOR CERVICAL SPINE SYSTEM by Electro-Biology, Inc. — Product Code KWQ

K955730 is an FDA 510(k) premarket notification submitted by Electro-Biology, Inc. for the device "EBI ANTERIOR CERVICAL SPINE SYSTEM". The FDA issued a decision of SN on March 13, 1996. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Electro-Biology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 13, 1996
Date Received
December 18, 1995
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