K091263 is an FDA 510(k) clearance for the ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35). This device is classified as a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II - Special Controls, product code JWH).
Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on November 19, 2009, 203 days after receiving the submission on April 30, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K091263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2009 |
| Decision Date | November 19, 2009 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |