K922238 is an FDA 510(k) clearance for the LEAPLAZA FRAME. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Spintech, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 23, 1992, 224 days after receiving the submission on May 13, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K922238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1992 |
| Decision Date | December 23, 1992 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | KWP - Appliance, Fixation, Spinal Interlaminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3050 |