The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Zimmer Patient Specific Instruments System.
| Device ID | K121640 |
| 510k Number | K121640 |
| Device Name: | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001 |
| Contact | Alexandra Razzhivina |
| Correspondent | Alexandra Razzhivina MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-04 |
| Decision Date | 2012-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314005970000290 | K121640 | 000 |
| E314005970000250 | K121640 | 000 |
| E31400597000029 | K121640 | 000 |
| E31400597000025 | K121640 | 000 |