Open Radiotransparent Intersomatic Implant (Roi)
FDA 510(k) K043349 · Ldr Spine USA
510(k) numberK043349
Submission
- Device name
- Open Radiotransparent Intersomatic Implant (Roi)
- Applicant
- Ldr Spine USA
Austin, TX, US - Received
- December 6, 2004
- Decision date
- June 29, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
More from Corelink, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K162133 | VerteFIT Corpectomy Cage SystemMQP · Traditional | 05/16/2017SE |
| K161173 | Avenue® T TLIF CageOVD · Traditional | 09/28/2016SE |
| K161798 | FacetBRIDGE® SystemMRW · Special | 08/04/2016SE |
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…MAX · Traditional | 03/31/2016SE |
| K152137 | FacetBRIDGE SystemMRW · Traditional | 01/25/2016SE |
| K151934 | ROI-C Titanium-Coated Implant SystemOVE · Traditional | 12/07/2015SE |
| K150765 | LDR Spine ROI-C Cervical Cage SystemOVE · Traditional | 09/17/2015SE |
| K142645 | Avenue T TLIF CageOVD · Traditional | 06/11/2015SE |
| K133363 | Interbridge Interspinous Posterior Fixation SystemPEK · Traditional | 03/07/2014SE |
| K123134 | Easyspine SystemNKB · Traditional | 02/01/2013SE |
Questions and answers
When was Open Radiotransparent Intersomatic Implant (Roi) cleared by the FDA?
Open Radiotransparent Intersomatic Implant (Roi) (K043349) received a 510(k) decision of Substantially Equivalent on June 29, 2005, 205 days after the submission was received.
What is the product code of K043349?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.