Clearance Summary
K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage received FDA 510(k) clearance under submission number K212038, sponsored by K&J Consulting Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-08-27.
- Submission: K212038
- Applicant / Sponsor: K&J Consulting Corporation
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2021-08-27
Classification & Regulation
This clearance is catalogued under FDA product code ODP and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.