510(k) K990351
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1999
- Date Received
- February 5, 1999
- 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