K991538 is an FDA 510(k) clearance for the OPERA CUPFLANGED ACETABULAR COMPONENTS. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Smith & Nephew, Inc., Orthopaedic Div. (Memphis, US). The FDA issued a Cleared decision on June 3, 1999, 31 days after receiving the submission on May 3, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K991538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1999 |
| Decision Date | June 03, 1999 |
| Days to Decision | 31 days |
| Submission Type | Abbreviated |
| 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 |