DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
FDA 510(k) K180215 · Life Spine, Inc.
510(k) numberK180215
Submission
- Device name
- DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
- Applicant
- Life Spine, Inc.
Huntley, IL, US - Received
- January 25, 2018
- Decision date
- September 13, 2018
- 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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Questions and answers
When was DYNA-LINK ELITE Stand-Alone Anterior Lumbar System cleared by the FDA?
DYNA-LINK ELITE Stand-Alone Anterior Lumbar System (K180215) received a 510(k) decision of Substantially Equivalent on September 13, 2018, 231 days after the submission was received.
What is the product code of K180215?
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.