510(k) K000594
K000594 is an FDA 510(k) premarket notification submitted by Stryker Leibinger for the device "LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE". The FDA issued a decision of Substantially Equivalent on December 8, 2000. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Stryker Leibinger has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 2000
- Date Received
- February 22, 2000
- 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