The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Planne.
| Device ID | K113829 |
| 510k Number | K113829 |
| Device Name: | ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Contact | Alexandra Razzhivina |
| Correspondent | Alexandra Razzhivina MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-27 |
| Decision Date | 2012-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314005970000190 | K113829 | 000 |
| E31400597000016 | K113829 | 000 |
| E31400597000017 | K113829 | 000 |
| E31400597000018 | K113829 | 000 |
| E31400597000019 | K113829 | 000 |
| E314005970000150 | K113829 | 000 |
| E314005970000160 | K113829 | 000 |
| E314005970000170 | K113829 | 000 |
| E314005970000180 | K113829 | 000 |
| E31400597000015 | K113829 | 000 |