K031219 is an FDA 510(k) clearance for the MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR). This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Orthofix, Inc. (Mckinney, US). The FDA issued a Cleared decision on May 28, 2003, 41 days after receiving the submission on April 17, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K031219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2003 |
| Decision Date | May 28, 2003 |
| Days to Decision | 41 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSB — Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |