Acetabular Cup Orientation System
FDA 510(k) clearance K150780 · decided 2015-10-27
Clearance details
- K-number
- K150780
- Device name
- Acetabular Cup Orientation System
- Applicant
- Materialise NV
- Decision
- Substantially Equivalent
- Date received
- 2015-03-25
- Decision date
- 2015-10-27
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- PLW
- Device class
- 2
- Regulation number
- 888.3350
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Leuven, BE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.