K897141 is an FDA 510(k) clearance for the SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO. This device is classified as a Implant, Fixation Device, Spinal (Class II - Special Controls, product code JDN).
Submitted by Stuart (Greensburg, US). The FDA issued a Cleared decision on June 21, 1990, 176 days after receiving the submission on December 27, 1989.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K897141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | December 27, 1989 |
| Decision Date | June 21, 1990 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDN — Implant, Fixation Device, Spinal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |