K123604 is an FDA 510(k) clearance for the ABG III 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 Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on August 16, 2013, 268 days after receiving the submission on November 21, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K123604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2012 |
| Decision Date | August 16, 2013 |
| Days to Decision | 268 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 |