510(k) K043297
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2005
- Date Received
- November 29, 2004
- Clearance Type
- Special
- 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