Clearance Summary
ORTHOSIS BANDAGES received FDA 510(k) clearance under submission number K810877, sponsored by Ortho-Cast, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1981-04-17.
- Submission: K810877
- Applicant / Sponsor: Ortho-Cast, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3025
- Decision date: 1981-04-17
Classification & Regulation
This clearance is catalogued under FDA product code ITG and 21 CFR 890.3025, within the Physical Medicine review panel as a Class I device.