K153602 is an FDA 510(k) clearance for the Materialise Glenoid Positioning System. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWS).
Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on April 26, 2016, 131 days after receiving the submission on December 17, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660.
| 510(k) Number | K153602 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2015 |
| Decision Date | April 26, 2016 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |