EBI Lactosorb Graft Containment System
by Ebi, L.P. 510(k)
Active
510(k) K033918
Overview
The EBI Lactosorb Graft Containment System is a device designed to maintain the relative position of weak bony tissue, such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. It is also indicated for cement restriction in total joint arthroplasty procedures when used in conjunction with traditional rigid fixation.
The device is supplied as a single-use, sterile system and is intended for use in orthopedic procedures. It is not MRI safe and should be stored in a controlled environment. The device has received FDA 510(k) clearance under K033918.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033918 | Date16 Aug 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent