Expedium Spine System Spinous Process Fusion Plate
FDA 510(k) K050675 · Depuy Spine, Inc.
510(k) numberK050675
Submission
- Device name
- Expedium Spine System Spinous Process Fusion Plate
- Applicant
- Depuy Spine, Inc.
Raynham, MA, US - Received
- March 16, 2005
- Decision date
- April 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Expedium Spine System Spinous Process Fusion Plate cleared by the FDA?
Expedium Spine System Spinous Process Fusion Plate (K050675) received a 510(k) decision of Substantially Equivalent on April 11, 2005, 26 days after the submission was received.
What is the product code of K050675?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.