The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for Modification To Iskd (intramedullary Skeletal Kinetic Distractor).
| Device ID | K031219 |
| 510k Number | K031219 |
| Device Name: | MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ORTHOFIX, INC. 1720 BRAY CENTRAL DR. Mckinney, TX 75069 |
| Contact | Mary Biggers |
| Correspondent | Mary Biggers ORTHOFIX, INC. 1720 BRAY CENTRAL DR. Mckinney, TX 75069 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-17 |
| Decision Date | 2003-05-28 |
| Summary: | summary |