Clearance Summary
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 received FDA 510(k) clearance under submission number K091190, sponsored by Zimmer Spine, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2009-07-30.
- Submission: K091190
- Applicant / Sponsor: Zimmer Spine, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3010
- Decision date: 2009-07-30
Classification & Regulation
This clearance is catalogued under FDA product code JDQ and 21 CFR 888.3010, within the Orthopedic review panel as a Class II device.