K834515 is an FDA 510(k) clearance for the FIXATION STAPLE KIT - DLIDE HAMMER. This device is classified as a Staple Driver (Class I - General Controls, product code HXJ).
Submitted by Stryker Corp. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984, 124 days after receiving the submission on December 21, 1983.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K834515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1983 |
| Decision Date | April 23, 1984 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HXJ — Staple Driver |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |