510(k) K040983
K040983 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "LORENZ SELF-DRILLING IMF SCREW". The FDA issued a decision of Substantially Equivalent on May 5, 2004. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2004
- Date Received
- April 15, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type