510(k) K130427

PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM by Pioneer Surgical Technology, Inc. — Product Code KWQ

K130427 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. for the device "PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 5, 2013. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Pioneer Surgical Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2013
Date Received
February 20, 2013
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