Clearance Summary
POLI-AXIAL KNEE CAGE received FDA 510(k) clearance under submission number K812064, sponsored by Generation II Orthotics, 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 1981-08-13.
- Submission: K812064
- Applicant / Sponsor: Generation II Orthotics, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3475
- Decision date: 1981-08-13
Classification & Regulation
This clearance is catalogued under FDA product code ITM and 21 CFR 890.3475, within the Physical Medicine review panel as a Class I device.