510(k) K031855
K031855 is an FDA 510(k) premarket notification submitted by Spinal Concepts, Inc. for the device "SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on September 17, 2003. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Spinal Concepts, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2003
- Date Received
- June 16, 2003
- 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