Depuy Spine Lateral System
FDA 510(k) K090899 · Depuy Spine, Inc.
510(k) numberK090899
Submission
- Device name
- Depuy Spine Lateral System
- Applicant
- Depuy Spine, Inc.
Raynham, MA, US - Received
- April 1, 2009
- Decision date
- May 19, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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| K110216 | Expedium System, Viper SystemNKB · Special | 04/01/2011SE |
| K103133 | Veper System, Expedium SystemNKB · Special | 01/18/2011SE |
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Questions and answers
When was Depuy Spine Lateral System cleared by the FDA?
Depuy Spine Lateral System (K090899) received a 510(k) decision of Substantially Equivalent on May 19, 2009, 48 days after the submission was received.
What is the product code of K090899?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.