Midline II Ti
FDA 510(k) K141942 · Centinel Spine, Inc.
510(k) numberK141942
Submission
- Device name
- Midline II Ti
- Applicant
- Centinel Spine, Inc.
Washington, DC, US - Received
- July 17, 2014
- Decision date
- November 7, 2014
- 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 Midline II Ti cleared by the FDA?
Midline II Ti (K141942) received a 510(k) decision of Substantially Equivalent on November 7, 2014, 113 days after the submission was received.
What is the product code of K141942?
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.