K837776 is an FDA 510(k) clearance for the AOR X-RAY ALIGMENT PAD. This device is classified as a Grid, Radiographic (Class I - General Controls, product code IXJ).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 18, 1983, 229 days after receiving the submission on January 1, 1983.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1910.
| 510(k) Number | K837776 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 01, 1983 |
| Decision Date | August 18, 1983 |
| Days to Decision | 229 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IXJ — Grid, Radiographic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1910 |