K110807 is an FDA 510(k) clearance for the ABG II MONOLITHIC HIP STEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish (Class II - Special Controls, product code MAY).
Submitted by Stryker Corp. (Mahwah, US). The FDA issued a Cleared decision on May 25, 2011, 63 days after receiving the submission on March 23, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K110807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2011 |
| Decision Date | May 25, 2011 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MAY — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |