510(k) K092743
K092743 is an FDA 510(k) premarket notification submitted by Stryker Craniomaxillofacial for the device "THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 15, 2010. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Stryker Craniomaxillofacial has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 15, 2010
- Date Received
- Sep 8, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type