510(k) K122216

RELIANCE ANTERIOR CERVICAL PLATE SYSTEM by Reliance Medical Systems, LLC — Product Code KWQ

K122216 is an FDA 510(k) premarket notification submitted by Reliance Medical Systems, LLC for the device "RELIANCE ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on Sep 5, 2012. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Reliance Medical Systems, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 5, 2012
Date Received
Jul 25, 2012
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