K023743 is an FDA 510(k) clearance for the SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II - Special Controls, product code KWY).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on January 23, 2003, 77 days after receiving the submission on November 7, 2002.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3390.
| 510(k) Number | K023743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2002 |
| Decision Date | January 23, 2003 |
| Days to Decision | 77 days |
| Submission Type | Abbreviated |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3390 |