Clearance Summary
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 received FDA 510(k) clearance under submission number K981423, sponsored by Autogenesis, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1998-05-20.
- Submission: K981423
- Applicant / Sponsor: Autogenesis, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1998-05-20
Classification & Regulation
This clearance is catalogued under FDA product code JEC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.