K890185 is an FDA 510(k) clearance for the C-S IMPACTOR. This device is classified as a Accessories, Fixation, Spinal Interlaminal (Class II — Special Controls, product code LYP).
Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on April 6, 1989, 78 days after receiving the submission on January 18, 1989.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K890185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 1989 |
| Decision Date | April 06, 1989 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LYP — Accessories, Fixation, Spinal Interlaminal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3050 |