Clearance Summary
SCHULTZ METACARPAL COMPONENT DRIVER received FDA 510(k) clearance under submission number K870848, sponsored by Warsaw Orthopedic, 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 1987-03-13.
- Submission: K870848
- Applicant / Sponsor: Warsaw Orthopedic, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1987-03-13
Classification & Regulation
This clearance is catalogued under FDA product code HWR and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.