The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Zimmer Patient Specific Instruments Planner.
| Device ID | K112301 |
| 510k Number | K112301 |
| Device Name: | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, 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 | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-10 |
| Decision Date | 2012-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314005970000040 | K112301 | 000 |
| E31400597000004 | K112301 | 000 |