510(k) K950709

SYNERGY TI ANTERIOR SPINAL SYSTEM by Cross Medical Products, Inc. — Product Code KWQ

K950709 is an FDA 510(k) premarket notification submitted by Cross Medical Products, Inc. for the device "SYNERGY TI ANTERIOR SPINAL SYSTEM". The FDA issued a decision of SN on October 25, 1995. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Cross Medical Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
October 25, 1995
Date Received
February 13, 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