The following data is part of a premarket notification filed by Materialise Nv with the FDA for Materialise Glenoid Positioning System.
| Device ID | K153602 |
| 510k Number | K153602 |
| 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 | 2015-12-17 |
| Decision Date | 2016-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420060361012 | K153602 | 000 |
| E31480425148 | K153602 | 000 |
| E314804030580 | K153602 | 000 |
| E31480403058 | K153602 | 000 |
| E314804030570 | K153602 | 000 |
| E31480403057 | K153602 | 000 |
| E314SHCLM0201010 | K153602 | 000 |
| E314SHCLM020101 | K153602 | 000 |
| E314SHCLM0101010 | K153602 | 000 |
| E314804251480 | K153602 | 000 |
| E314SHCLM010001 | K153602 | 000 |
| E314SHCLM0100010 | K153602 | 000 |
| E314SHCLM1000010 | K153602 | 000 |
| E314SHCLM100001 | K153602 | 000 |
| E314SHCLM0202010 | K153602 | 000 |
| E314SHCLM020201 | K153602 | 000 |
| E314SHCLM0200010 | K153602 | 000 |
| E314SHCLM020001 | K153602 | 000 |
| E314SHCLM0102010 | K153602 | 000 |
| E314SHCLM010201 | K153602 | 000 |
| E314SHCLM010101 | K153602 | 000 |