Acetabular Cup Orientation System
FDA 510(k) K150780 · Materialise NV
510(k) numberK150780
Submission
- Device name
- Acetabular Cup Orientation System
- Applicant
- Materialise NV
Leuven, BE - Received
- March 25, 2015
- Decision date
- October 27, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLW – Acetabular Cup Orientation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative imaging scans.
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Questions and answers
When was Acetabular Cup Orientation System cleared by the FDA?
Acetabular Cup Orientation System (K150780) received a 510(k) decision of Substantially Equivalent on October 27, 2015, 216 days after the submission was received.
What is the product code of K150780?
The FDA product code is PLW – Acetabular Cup Orientation System, a Class II (moderate risk) device regulated under 21 CFR 888.3350.