510(k) K092420
K092420 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "KRD1 PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on Nov 19, 2009. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Spinefrontier, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 19, 2009
- Date Received
- Aug 6, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Orthosis, Spinal Pedicle Fixation
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
- 510(k)