The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Zimmer Patient Specific Instruments System, Version 2.0.
| Device ID | K093533 |
| 510k Number | K093533 |
| Device Name: | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001 |
| Contact | Karl Vom Berge |
| Correspondent | Karl Vom Berge MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-16 |
| Decision Date | 2010-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314005970000030 | K093533 | 000 |
| E31400597000003 | K093533 | 000 |