Modification to CD Horizon Spinal System
FDA 510(k) K040072 · Medtronic Sofamor Danek, Inc.
510(k) numberK040072
Submission
- Device name
- Modification to CD Horizon Spinal System
- Applicant
- Medtronic Sofamor Danek, Inc.
Memphis, TN, US - Received
- January 14, 2004
- Decision date
- February 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal 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 Modification to CD Horizon Spinal System cleared by the FDA?
Modification to CD Horizon Spinal System (K040072) received a 510(k) decision of Substantially Equivalent on February 12, 2004, 29 days after the submission was received.
What is the product code of K040072?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.