K990345 is an FDA 510(k) clearance for the RABEA DEVICE, MODEL PXXXXXX. This device is classified as a Prosthesis, Hip, Cement Restrictor (Class II - Special Controls, product code JDK).
Submitted by Signus Medizintechnik GmbH (Shorewood, US). The FDA issued a Cleared decision on July 30, 1999, 176 days after receiving the submission on February 4, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K990345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | February 04, 1999 |
| Decision Date | July 30, 1999 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDK — Prosthesis, Hip, Cement Restrictor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |