Clearance Summary
TRACER BONE MILL received FDA 510(k) clearance under submission number K883183, sponsored by De Medica Mfg., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1988-10-12.
- Submission: K883183
- Applicant / Sponsor: De Medica Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1988-10-12
Classification & Regulation
This clearance is catalogued under FDA product code LYS and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.