The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Contours Lapidus Plating System.
| Device ID | K102201 |
| 510k Number | K102201 |
| Device Name: | CONTOURS LAPIDUS PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-04 |
| Decision Date | 2010-12-15 |
| Summary: | summary |