510(k) K024326

SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM by Spinal Concepts, Inc. — Product Code KWQ

K024326 is an FDA 510(k) premarket notification submitted by Spinal Concepts, Inc. for the device "SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 23, 2003. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Spinal Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2003
Date Received
December 26, 2002
Clearance Type
Special
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