K080842 is an FDA 510(k) clearance for the APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]. This device is classified as a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II - Special Controls, product code MBH).
Submitted by Omni Life Science, Inc. (Raynham, US). The FDA issued a Cleared decision on May 23, 2008, 59 days after receiving the submission on March 25, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3565.
| 510(k) Number | K080842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2008 |
| Decision Date | May 23, 2008 |
| Days to Decision | 59 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBH - Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3565 |