510(k) K973836
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