510(k) K801010
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1980
- Date Received
- April 28, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rod, Fixation, Intramedullary And Accessories
- Device Class
- Class II
- Regulation Number
- 888.3020
- Review Panel
- OR
- Submission Type