The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner, Model 1.1 (4.3.0.35).
| Device ID | K091263 |
| 510k Number | K091263 |
| Device Name: | ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001 |
| Contact | Karl Von Berge |
| Correspondent | Karl Von Berge 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 | 2009-04-30 |
| Decision Date | 2009-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314005970000100 | K091263 | 000 |
| E314005970000020 | K091263 | 000 |
| E314005970000010 | K091263 | 000 |
| E31400597000002 | K091263 | 000 |
| E31400597000001 | K091263 | 000 |