K974406 is an FDA 510(k) clearance for the ORTHOPLAN. This device is classified as a Template (Class I - General Controls, product code HWT).
Submitted by Ortho-Graphics, Inc. (Saltlake, US). The FDA issued a Cleared decision on February 18, 1998, 89 days after receiving the submission on November 21, 1997.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4800.
| 510(k) Number | K974406 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1997 |
| Decision Date | February 18, 1998 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HWT — Template |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4800 |