510(k) K940744
K940744 is an FDA 510(k) premarket notification submitted by Sofamor Co. for the device "SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION". The FDA issued a decision of SN on January 30, 1996. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Sofamor Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- January 30, 1996
- Date Received
- February 17, 1994
- 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