Clearance Summary
2GC HIP/KNEE MODULAR SPACER received FDA 510(k) clearance under submission number K112470, sponsored by Mandell Horwitz Consultants, 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 2012-04-05.
- Submission: K112470
- Applicant / Sponsor: Mandell Horwitz Consultants, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3360
- Decision date: 2012-04-05
Classification & Regulation
This clearance is catalogued under FDA product code KWL and 21 CFR 888.3360, within the Orthopedic review panel as a Class II device.