Clearance Summary
THE EXTRACTOR I TM received FDA 510(k) clearance under submission number K801327, sponsored by The Anspach Effort, 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 1980-06-09.
- Submission: K801327
- Applicant / Sponsor: The Anspach Effort, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1980-06-09
Classification & Regulation
This clearance is catalogued under FDA product code HWB and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.