Clearance Summary
DePuy Synthes Sterilization Container System received FDA 510(k) clearance under submission number K181933, sponsored by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2019-05-09.
- Submission: K181933
- Applicant / Sponsor: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2019-05-09
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.