Clearance Summary
SEVIIN SURFACE REPLACEMENT SHOULDER received FDA 510(k) clearance under submission number K130635, sponsored by Ingen Orthopedics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-08-26.
- Submission: K130635
- Applicant / Sponsor: Ingen Orthopedics, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3690
- Decision date: 2013-08-26
Classification & Regulation
This clearance is catalogued under FDA product code HSD and 21 CFR 888.3690, within the Orthopedic review panel as a Class II device.