LDR Spine Roi-A Interbody Fusion System
FDA 510(k) K110327 · Ldr Spine USA
510(k) numberK110327
Submission
- Device name
- LDR Spine Roi-A Interbody Fusion System
- Applicant
- Ldr Spine USA
Austin, TX, US - Received
- February 3, 2011
- Decision date
- September 30, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
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|---|---|---|---|
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| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
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| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
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| K133363 | Interbridge Interspinous Posterior Fixation SystemPEK · Traditional | 03/07/2014SE |
| K123134 | Easyspine SystemNKB · Traditional | 02/01/2013SE |
Questions and answers
When was LDR Spine Roi-A Interbody Fusion System cleared by the FDA?
LDR Spine Roi-A Interbody Fusion System (K110327) received a 510(k) decision of Substantially Equivalent on September 30, 2011, 239 days after the submission was received.
What is the product code of K110327?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.