Obelisc Vertebral Body Replacement Device
FDA 510(k) K060416 · Ulrich GmbH & Co. KG
510(k) numberK060416
Submission
- Device name
- Obelisc Vertebral Body Replacement Device
- Applicant
- Ulrich GmbH & Co. KG
Clearwater, FL, US - Received
- February 17, 2006
- Decision date
- December 26, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Obelisc Vertebral Body Replacement Device cleared by the FDA?
Obelisc Vertebral Body Replacement Device (K060416) received a 510(k) decision of Substantially Equivalent on December 26, 2006, 312 days after the submission was received.
What is the product code of K060416?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.