510(k) K893415
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 1989
- Date Received
- May 2, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Fixation, Spinal Intervertebral Body
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type