510(k) K150780
- Device
- Acetabular Cup Orientation System
- Applicant
- MATERIALISE NV
- 510(k) number
- K150780
- Product code
- PLW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-10-27
- Date received
- 2015-03-25
- Regulation
- 888.3350
- Classification name
- Acetabular Cup Orientation System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- OLIVER CLEMENS
- Address
- Technologielaan 15 Leuven BE 3001 3001
FDA Registration Numbers#
- 3012916784
Source Documents#
Legacy Summary#
summary
FDA Review#
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