The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments.
| Device ID | K111492 |
| 510k Number | K111492 |
| Device Name: | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS |
| 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 | 2011-05-31 |
| Decision Date | 2011-10-13 |
| Summary: | summary |