Clearance Summary
CROSS MEDICAL PRODUCT PEDICLE AWL received FDA 510(k) clearance under submission number K895587, sponsored by Cross Medical Products, 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 1990-01-04.
- Submission: K895587
- Applicant / Sponsor: Cross Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1990-01-04
Classification & Regulation
This clearance is catalogued under FDA product code HWJ and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.