K843445 is an FDA 510(k) clearance for the SACRAL BAR. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Stuart (Greensburg, US). The FDA issued a Cleared decision on February 13, 1985, 161 days after receiving the submission on September 5, 1984.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K843445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1984 |
| Decision Date | February 13, 1985 |
| Days to Decision | 161 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 |