The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Zimmer Patient Specific Instruments/ System/planner.
| Device ID | K140027 |
| 510k Number | K140027 |
| Device Name: | ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Contact | Oliver Clemens |
| Correspondent | Oliver Clemens MATERIALISE N.V. TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Product Code | JWH |
| Subsequent Product Code | MBH |
| Subsequent Product Code | OIY |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-06 |
| Decision Date | 2014-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E314ZIMMERPSIP0 | K140027 | 000 |
| E314005970000480 | K140027 | 000 |
| E314005970000450 | K140027 | 000 |
| E314005970000420 | K140027 | 000 |
| E314005970000390 | K140027 | 000 |
| E31400597000048 | K140027 | 000 |
| E31400597000045 | K140027 | 000 |
| E31400597000042 | K140027 | 000 |