K831128 is an FDA 510(k) clearance for the BARD INTRAMEDULLARY PLUG. This device is classified as a Prosthesis, Hip, Cement Restrictor (Class II - Special Controls, product code JDK).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1983, 97 days after receiving the submission on April 6, 1983.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K831128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1983 |
| Decision Date | July 12, 1983 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDK — Prosthesis, Hip, Cement Restrictor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |