K801080 is an FDA 510(k) clearance for the EDWARDS ROD SLEEVES. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Zimmer, Inc. (Walker, US). The FDA issued a Cleared decision on May 20, 1980, 13 days after receiving the submission on May 7, 1980.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K801080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1980 |
| Decision Date | May 20, 1980 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KWP — Appliance, Fixation, Spinal Interlaminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3050 |