The following data is part of a premarket notification filed by Materialise Nv with the FDA for Acetabular Cup Orientation System.
| Device ID | K150780 |
| 510k Number | K150780 |
| Device Name: | Acetabular Cup Orientation System |
| Classification | Acetabular Cup Orientation System |
| Applicant | MATERIALISE NV TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Contact | Oliver Clemens |
| Correspondent | Oliver Clemens MATERIALISE NV TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Product Code | PLW |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-25 |
| Decision Date | 2015-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314O02055700000113000 | K150780 | 000 |
| E314O0205570000011300 | K150780 | 000 |
| E314HPCCO0102010 | K150780 | 000 |
| E314HPCCO010201 | K150780 | 000 |
| E314HPCCO010101 | K150780 | 000 |
| E314HPCCO010001 | K150780 | 000 |
| E314ACOPLANNER0 | K150780 | 000 |