K090411 is an FDA 510(k) clearance for the FREEDOM METAL BACKED TIBIAL COMPONENT. This device is classified as a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II - Special Controls, product code JWH).
Submitted by Maxx Orthopedics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on April 7, 2009, 48 days after receiving the submission on February 18, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K090411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2009 |
| Decision Date | April 07, 2009 |
| Days to Decision | 48 days |
| Submission Type | Special |
| 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 |