K833952 is an FDA 510(k) clearance for the FIXATION PINS. This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984, 86 days after receiving the submission on November 16, 1983.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K833952 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 1983 |
| Decision Date | February 10, 1984 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HTY — Pin, Fixation, Smooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |