LDR Spine USA Avenue L Interbody Fusion
FDA 510(k) K113285 · Ldr Spine USA, Inc.
510(k) numberK113285
Submission
- Device name
- LDR Spine USA Avenue L Interbody Fusion
- Applicant
- Ldr Spine USA, Inc.
Austin, TX, US - Received
- November 7, 2011
- Decision date
- July 26, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
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| 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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Questions and answers
When was LDR Spine USA Avenue L Interbody Fusion cleared by the FDA?
LDR Spine USA Avenue L Interbody Fusion (K113285) received a 510(k) decision of Substantially Equivalent on July 26, 2012, 262 days after the submission was received.
What is the product code of K113285?
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.