Clearance Summary
EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM received FDA 510(k) clearance under submission number K094035, sponsored by Stelkast Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-03-24.
- Submission: K094035
- Applicant / Sponsor: Stelkast Company
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2011-03-24
Classification & Regulation
This clearance is catalogued under FDA product code OQG and 21 CFR 888.3358, within the Orthopedic review panel as a Class II device.