Clearance Summary
Medline ReNewal Reprocessed Stryker External Fixation Devices received FDA 510(k) clearance under submission number K163028, sponsored by Surgical Instrument Service and Savings, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-12-28.
- Submission: K163028
- Applicant / Sponsor: Surgical Instrument Service and Savings, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2016-12-28
Classification & Regulation
This clearance is catalogued under FDA product code JEC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.