K861988 is an FDA 510(k) clearance for the MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 11, 1987, 278 days after receiving the submission on May 9, 1986.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K861988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1986 |
| Decision Date | February 11, 1987 |
| Days to Decision | 278 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3350 |