K843370 is an FDA 510(k) clearance for the IMSI/METRIPOND GRIPPER PLATE. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Intl. Management Services, Inc. (Lincoln, US). The FDA issued a Cleared decision on January 23, 1985, 148 days after receiving the submission on August 28, 1984.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K843370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1984 |
| Decision Date | January 23, 1985 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |