K780266 is an FDA 510(k) clearance for the BONE CEMENT APPLICATOR. This device is classified as a Dispenser, Cement (Class I - General Controls, product code KIH).
Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1978, 11 days after receiving the submission on February 17, 1978.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4200.
| 510(k) Number | K780266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1978 |
| Decision Date | February 28, 1978 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KIH — Dispenser, Cement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4200 |