Clearance Summary
Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK received FDA 510(k) clearance under submission number K143572, sponsored by Osteomed Implantes, Ltda. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2015-06-10.
- Submission: K143572
- Applicant / Sponsor: Osteomed Implantes, Ltda
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2015-06-10
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.