K061344 is an FDA 510(k) clearance for the EXCIA TOTAL HIP SYSTEM LATERAL OFFSET. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on August 2, 2006, 79 days after receiving the submission on May 15, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K061344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2006 |
| Decision Date | August 02, 2006 |
| Days to Decision | 79 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3350 |