Clearance Summary
MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT received FDA 510(k) clearance under submission number K854887, sponsored by Walter Lorenz Surgical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1986-02-28.
- Submission: K854887
- Applicant / Sponsor: Walter Lorenz Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1986-02-28
Classification & Regulation
This clearance is catalogued under FDA product code EMH and 21 CFR 872.4565, within the Dental review panel as a Class I device.