Ebi Lactosorb Graft Containment System
FDA 510(k) K033918 · Ebi, L.P.
510(k) numberK033918
Submission
- Device name
- Ebi Lactosorb Graft Containment System
- Applicant
- Ebi, L.P.
Parsippany, NJ, US - Received
- December 18, 2003
- Decision date
- August 16, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K100438 | Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemNKB · Special | 06/23/2010SE |
| K100220 | Polaris Spinal SystemNKB · Special | 05/17/2010SE |
| K093880 | Peanut Growth Control Plating SystemHRS · Traditional | 04/16/2010SE |
| K092574 | Esl Spinal SystemMAX · Traditional | 02/04/2010SE |
| K093057 | Biomet Vision Footring SystemKTT · Traditional | 12/01/2009SE |
| K092336 | C-Thru Spinal SystemMQP · Traditional | 10/15/2009SE |
| K091381 | Ibex Spinal SystemMAX · Traditional | 08/07/2009SE |
| K090203 | 5.5 Helical Flange Spinal System, Polaris ComponentsNKB · Special | 07/30/2009SE |
| K090523 | Polaris Spinal SystemNKB · Traditional | 07/01/2009SE |
| K082406 | Expandable Peek-Optima ImplantMAX · Traditional | 01/14/2009SE |
Questions and answers
When was Ebi Lactosorb Graft Containment System cleared by the FDA?
Ebi Lactosorb Graft Containment System (K033918) received a 510(k) decision of Substantially Equivalent on August 16, 2004, 242 days after the submission was received.
What is the product code of K033918?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.