K891539 is an FDA 510(k) clearance for the CTI II STRAIGHT STEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (Class II - Special Controls, product code LWJ).
Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on June 8, 1989, 83 days after receiving the submission on March 17, 1989.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K891539 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1989 |
| Decision Date | June 08, 1989 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LWJ — Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |