Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides
FDA 510(k) K132290 · Materialise NV
510(k) numberK132290
Submission
- Device name
- Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides
- Applicant
- Materialise NV
Leuven, BE - Received
- July 23, 2013
- Decision date
- April 10, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBF – Orthopaedic Surgical Planning And Instrument Guides
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.
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Questions and answers
When was Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides cleared by the FDA?
Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides (K132290) received a 510(k) decision of Substantially Equivalent on April 10, 2014, 261 days after the submission was received.
What is the product code of K132290?
The FDA product code is PBF – Orthopaedic Surgical Planning And Instrument Guides, a Class II (moderate risk) device regulated under 21 CFR 888.3030.