The following data is part of a premarket notification filed by Materialise Nv with the FDA for Materialise Glenoid Positioning System.
| Device ID | K170893 |
| 510k Number | K170893 |
| Device Name: | Materialise Glenoid Positioning System |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Contact | Oliver Clemens |
| Correspondent | Oliver Clemens Materialise NV Technologielaan 15 Leuven, BE 3001 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-27 |
| Decision Date | 2017-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314804070220 | K170893 | 000 |