510(k) K792352

SYNTHES CERVICAL VERTABRAE PLATES by DePuy Synthes — Product Code KWQ

K792352 is an FDA 510(k) premarket notification submitted by DePuy Synthes for the device "SYNTHES CERVICAL VERTABRAE PLATES". The FDA issued a decision of Substantially Equivalent on December 6, 1979. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. DePuy Synthes has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1979
Date Received
November 19, 1979
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