K113242 is an FDA 510(k) clearance for the APEX ARC HIP STEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II - Special Controls, product code LPH).
Submitted by Omni Life Science, Inc. (East Taunton, US). The FDA issued a Cleared decision on January 5, 2012, 64 days after receiving the submission on November 2, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K113242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2011 |
| Decision Date | January 05, 2012 |
| Days to Decision | 64 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LPH - Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |