510(k) K973836

SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM by Cross Medical Products, Inc. — Product Code MNH

K973836 is an FDA 510(k) premarket notification submitted by Cross Medical Products, Inc. for the device "SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM". The FDA issued a decision of SN on March 5, 1998. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Cross Medical Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 5, 1998
Date Received
October 8, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type