510(k) K080778
K080778 is an FDA 510(k) premarket notification submitted by Sonoma Orthopedic Products, Inc. for the device "ENSPLINT TM BONE SCREW". The FDA issued a decision of Substantially Equivalent on Jul 10, 2008. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Sonoma Orthopedic Products, Inc. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 10, 2008
- Date Received
- Mar 19, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)